MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT CEMENTED STEM SZ2 STD; SUMMIT HIP STEM : HIP FEMORAL STEM

Catalog Number	157003080
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the broached size 2 summit cemented and when they implanted the final stem in the femoral canal after putting cement, the stem did not want to go down as the broach.They removed the finale implant before the cement got harden and removed the excess of cement.Surgery was delayed 30 minutes.
Additional 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.
Additional 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary i had a call from the surgeon intra-operative, saying that they broached up to size 2 summit cemented and when they implanted the final stem in the femoral canal after putting cement, the stem did not want to go down as the broach.They removed the finale implant before the cement got harden and removed the excess of cement.They finally ended with a stryker exeter xsmall the device associated with this report was returned to depuy synthes for evaluation.Visual inspection found nothing indicative of a device nonconformance.A dimensional inspection was not performed since it was not applicable to the complaint condition.Functional test was not performed since the alleged mating trial wa snot returned for a comparison with the implant.The overall complaint was not confirmed as the observed condition of the [summit cemented stem sz2 std] would not have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.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 manufacturing record evaluation were performed for product code 157003080, lot number d23011405, it was manufactured on 13-feb-2023.16pcs parts were manufactured per specification and all raw materials met specification.One non-conformance was found.The non-conformance has no relation with this complaint.Device history review a manufacturing record evaluation were performed for product code 157003080, lot number d23011405, it was manufactured on 13-feb-2023.16pcs parts were manufactured per specification and all raw materials met specification.One non-conformance was found.The non-conformance has no relation with this complaint.

• Brand Name: SUMMIT CEMENTED STEM SZ2 STD
• Common Device Name: SUMMIT HIP STEM : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17816345
• Report Number: 1818910-2023-19435
• Device Sequence Number: 6138022
• Product Code: JDI
• UDI-Device Identifier: 10603295059523
• UDI-Public: 10603295059523
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K170339
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 157003080
• Device Lot Number: D23011405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 11/07/2023; 11/21/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 11/08/2023; 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown