MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS CEM FEM STEM 11X200MM BOW; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Model Number	86-7428
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of a fractured cemented distal femoral stem left side.Doi: unknown dor: (b)(6) 2023.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Additional information received indicates that the patient was experiencing instability that led to the revision surgery and the initial implantation took place in another hospital in 2014.
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.H10 additional narrative: added: b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.D10 (updated the concomitant product unknown bone cement to palacos cement (competitor).
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: the device associated with this report was returned to depuy synthes for evaluation.Visual examination found the device broken at the shaft near the distal base of the stem, confirming the reported allegation.Additionally, heavy extraction damage can be identified.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 4/17/14.3) any anomalies or deviations identified in dhr: none.4) expiry date: 2024/02.5) ifu reference: 092-00-252 revk.Device history review: 1) quantity manufactured: (b)(4).2) date of manufacture: 4/17/14.3) any anomalies or deviations identified in dhr: none.4) expiry date: 2024/02.5) ifu reference: 092-00-252 revk.

• Brand Name: LPS CEM FEM STEM 11X200MM BOW
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16708866
• Report Number: 1818910-2023-07583
• Device Sequence Number: 18005892
• Product Code: JWH
• UDI-Device Identifier: 10603295078807
• UDI-Public: 10603295078807
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K003182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 04/10/2023

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: 12/31/2023
• Device Model Number: 86-7428
• Device Catalogue Number: 198715311
• Device Lot Number: 479256
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 05/04/2023; 06/13/2023; 07/05/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/10/2023; 06/27/2023; 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ETHISORB MEDULLARY PLUG UND; LPS CEM FEM STEM 11X200MM BOW; LPS DISTAL FEM COMP XSM LT; LPS UNIV TIB HIN INS XSM 12MM; MBT REV TIB TRAY SIZE 4 15MM; MBT TRAY SLEEVE POR M/L 53MM; PALACOS CEMENT (COMPETITOR); UNIVERSAL STEM 115X14MM FLUTED; UNKNOWN BONE CEMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male