MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EA DELTA CER INSERT 36IDX52OD; HIP CERAMIC ACETABULAR LINERS

Catalog Number 121881752

Device Problem Fracture (1260)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint #(b)(4).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

Liner breakage intra-op.When the patient underwent the surgery of right hip arthroplasty, the ceramic liner was fractured at the edge intra-op.After all fragments were removed, the other device was changed to complete the surgery.The surgery was extended for 20 mins.The patient was stable.

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.H10 additional narrative: added: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appro0priate.Corrected h3.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: liner breakage intra-op.When the patient underwent the surgery of right hip arthroplasty, the ceramic liner was fractured at the edge intra-op.After removed of all fragments, changed other device to complete the surgery.The surgery was extended for around 20 mins.The patient was in stable till now.The product was not returned to depuy synthes, however photos were provided for review.See attachment "complaint product picture of (b)(4).Review of the photographic evidence revealed that the ea delta cer insert 36idx52od has a portion of the rim fractured.Fragments cannot be observed on the provided evidence.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed damage of the ea delta cer insert 36idx52od may have been caused by misalignment during the process of positioning the insert.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A manufacturing record evaluation was performed for the finished device [121881752/ 4208194] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The component properties and the microstructure as obtained from the quality documents fulfil requirements as specified at the time of production.There is no indication of any pre -existing material defect.The overall complaint was confirmed as the observed condition of the ea delta cer insert 36idx52od would contribute to the complained device issue.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 reported 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: the ceramic insert belongs to the shop order (b)(4).Protocols and certificate of conformance were reviewed.The quality documents show that the data obtained on the insert confirmed to the specification valid at the time of production.The component properties and the microstructure as obtained from the quality documents fulfil requirements as specified at the time of production.There is no indication of any pre -existing material defect.Device history review: a manufacturing record evaluation was performed for the finished device [121881752/ 4208194] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information received, "liner breakage intra-op.When the patient underwent the surgery of right hip arthroplasty, the ceramic liner was fractured at the edge intra-op.After removed of all fragments, changed other device to complete the surgery.The surgery was extended for around 20 mins.The patient was in stable till now".The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device along with a manufacturing investigation performed by supplier.Visual analysis revealed that the rim of the ea delta cer insert 36idx52od has fractured into one (1) large and two (2) small fragments.Metal transfer of erratic appearance were observed all over the rim.Additionally, metal transfer patterns around the whole circumference of the taper that suggest a symmetrical taper fit between the liner and the acetabular cup cannot be found.Next to the fracture surface signs of metal transfer were found which indicates small areas of intensive contact between the ceramic liner and the acetabular cup, most likely due a tilted position of the liner during the impaction.There is no indication that a design or manufacturing issue has caused or contributed to the reported event.Although the liner failure cannot be traced to design or manufacturing, a definite root cause cannot be established.However in support of the evaluation performed, the observed damage of the liner may have been caused by a misalignment during the process of positioning the liner in the acetabular cup.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A manufacturing record evaluation was performed for the finished device [121881752 / 4208194] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The component properties and the microstructure as obtained from the quality documents fulfil requirements as specified at the time of production.There is no indication of any pre -existing material defect.The overall complaint was confirmed as the observed condition of the ea delta cer insert 36idx52od would contribute to the complained device issue.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 reported 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 : the ceramic insert belongs to the shop order (b)(4).Protocols and certificate of conformance were reviewed.The quality documents show that the data obtained on the insert confirmed to the specification valid at the time of production.The component properties and the microstructure as obtained from the quality documents fulfil requirements as specified at the time of production.There is no indication of any pre -existing material defect.Device history review : a manufacturing record evaluation was performed for the finished device [121881752/ 4208194] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: EA DELTA CER INSERT 36IDX52OD
• Type of Device: HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17998973
• MDR Text Key: 326463904
• Report Number: 1818910-2023-21647
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121881752
• Device Lot Number: 4208194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Female