MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM NRHFEM W/PIN MEDLFT 71X66; LPS AND S-ROM : KNEE FEMORAL

Catalog Number	623401L
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
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 that 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 : according to the information provided, it was reported that breakage of s-rom, primary surgery 2020 the product and photos (b)(4) were returned to depuy synthes for evaluation.The photos of the complaint unit were forwarded to the cpd (commercialized product development) for further information.Visual analysis review found the post of the srom nrhfem w/pin medlft 71x66 fractured.However it is worth mentioning that only the fractured post was returned logged inside the mating femoral sleeve.The sleeve was returned assembled with the stem and exhibits scratches, signs of extraction attempts.Meeting with the depuy warsaw cpd (commercialized product development) conclude that the fracture characteristics are consistent with low stress high cycle fatigue.No evidence of material or manufacturing defects were observed.Therefore, further material analysis activities beyond visual analysis were not performed with the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.A manufacturing record evaluation was performed for the finished device below and no non-conformances or manufacturing irregularities were identified.The overall complaint was confirmed as the observed condition of the srom nrhfem w/pin medlft 71x66 would have 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 : a manufacturing record evaluation was performed for the finished device below and no non-conformances or manufacturing irregularities were identified.
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.
Event or Problem Description
It was reported that patient was revised due to breakage of s-rom.Doi: on (b)(6) 2020.Doe: on (b)(6) 2024.Affected side: left.

• Brand Name: SROM NRHFEM W/PIN MEDLFT 71X66
• Common Device Name: LPS AND S-ROM : KNEE FEMORAL
• 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 46582
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19709242
• Report Number: 1818910-2024-14897
• Device Sequence Number: 14262656
• Product Code: JWH
• UDI-Device Identifier: 10603295179467
• UDI-Public: (01)10603295179467(10)J87G24(17)250630
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K870730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: 623401L
• Device Lot Number: J87G24
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 07/23/2024; 09/17/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 07/25/2024; 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male