MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT POR TAPER SZ5 HI OFF; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number 157011110

Device Problems Fracture (1260); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).H4: the manufacturing date is unidentified at this time.If additional information is received, a follow up regulatory report will be provided.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

During a hip arthroplasty, after trialing components the final stem was brought into the operating room and confirmed with the surgeon.Stem was opened and audible rattling was heard from the box.When the stem sterile casing was removed from the box, it was seen that the sterile containment was cracked and the stem was contaminated.There was no surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Additional information received states that there were no consequences for the patient as the implant was not used.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : during a hip arthroplasty, after trialing components the final stem was brought into the operating room and confirmed with the surgeon.Stem was opened and audible rattling was heard from the box.When the stem sterile casing was removed from the box, it was seen that the sterile containment was cracked and the stem was contaminated.The product was not returned to depuy synthes, however photos were provided for review.See (b)(4).The photo investigation was able to identify that the package is damaged and open/broken/warped on the side (the quality of the photos provided is not the best to fully determine the mode of failure), compromising the sterility of the device.However no breakage of the summit por taper sz5 hi off can be seen.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed for the [summit por taper sz5 hi off].The root cause of the complaint condition cannot be traced to a manufacturing facility.However, once the product leaves depuy synthes control, it is unknown what environment conditions the packaged products are exposed to during that time.Therefore the suspected cause is traced to transport/storage outside of depuy synthes control.The received condition of the device confirmed the reported allegation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: during a hip arthroplasty, after trialing components the final stem was brought into the operating room and confirmed with the surgeon.Stem was opened and audible rattling was heard from the box.When the stem sterile casing was removed from the box, it was seen that the sterile containment was cracked and the stem was contaminated.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that plastic blister was found damaged compromising the sterility of the device.The packing box was returned opened and warped.The device summit por taper sz5 hi off hasn't evidence of breakage.No other issues were observed.A dimensional inspection was not performed as it is not applicable to the complaint condition.The product leaves depuy synthes control, it is unknown what environment conditions the packaged products are exposed to during that time.Therefore the potential cause is traced to transport/storage outside of depuy synthes control.The received condition of the device confirmed the reported allegation.The overall complaint was confirmed as the observed condition of the summit por taper sz5 hi off would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

Manufacturer Narrative

Product complaint (b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: during a hip arthroplasty, after trialing components the final stem was brought into the operating room and confirmed with the surgeon.Stem was opened and audible rattling was heard from the box.When the stem sterile casing was removed from the box, it was seen that the sterile containment was cracked and the stem was contaminated.The product was not returned to depuy synthes, however photos were provided for review.See attachment "thumbnail_img_4015.Jpg, thumbnail_img_4016.Jpg, thumbnail_img_4017.Jpg, thumbnail_img_4018.Jpg:" the photo investigation was able to identify that the package is damaged and open/broken/warped on the side (the quality of the photos provided is not the best to fully determine the mode of failure), compromising the sterility of the device.However no breakage of the summit por taper sz5 hi off can be seen.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed for the [summit por taper sz5 hi off].The root cause of the complaint condition cannot be traced to a manufacturing facility.However, once the product leaves depuy synthes control, it is unknown what environment conditions the packaged products are exposed to during that time.Therefore the suspected cause is traced to transport/storage outside of depuy synthes control.The received condition of the device confirmed the reported allegation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: during a hip arthroplasty, after trialing components the final stem was brought into the operating room and confirmed with the surgeon.Stem was opened and audible rattling was heard from the box.When the stem sterile casing was removed from the box, it was seen that the sterile containment was cracked and the stem was contaminated.The product was not returned to depuy synthes, however photos were provided for review.See attachment "thumbnail_img_4015.Jpg, thumbnail_img_4016.Jpg, thumbnail_img_4017.Jpg, thumbnail_img_4018.Jpg:" the photo investigation was able to identify that the package is damaged and open/broken/warped on the side (the quality of the photos provided is not the best to fully determine the mode of failure), compromising the sterility of the device.However no breakage of the summit por taper sz5 hi off can be seen.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed for the [summit por taper sz5 hi off].The root cause of the complaint condition cannot be traced to a manufacturing facility.However, once the product leaves depuy synthes control, it is unknown what environment conditions the packaged products are exposed to during that time.Therefore the suspected cause is traced to transport/storage outside of depuy synthes control.The received condition of the device confirmed the reported allegation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: SUMMIT POR TAPER SZ5 HI OFF
• Type of Device: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18216654
• MDR Text Key: 329125284
• Report Number: 1818910-2023-24084
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295060062
• UDI-Public: 10603295060062
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 157011110
• Device Lot Number: M2950H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1