MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS FEM TO SLEEVE ADAPTER +10; LPS AND S-ROM : KNEE FEMORAL ACCESSORY

Model Number	1987-06-010
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Unspecified Musculoskeletal problem (4535)
Date of Event	06/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Implantation of an lps knee prosthesis: xsm femur and femor lps + 10 mm adapter (ref without intraoperative complication.Detection in consultation of a rotation disorder of the femur, which was not present on the intraoperative pictures related to a mismatch of the morse cone (either between the sleeve and the adapter or between the adapter and the femur).Major rotation disorder in external rotation of the femur with severe alteration of the flexion axis of the leg.Surgical revision for replacement of adapter and femoral implant (same manufacturer, same sizes).No intraoperative complications.
Event or Problem Description
Additional information received.A.What is the affected side: right knee.B.Was there a surgical delay? if yes, what was the duration of the delay? no delay, during the initial surgery.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this complaint was returned for examination.Visual examination found, the device still firmly attached to the femoral component.And nothing indicative of a device nonconformance could be seen.Not confirming, the reported allegation.However, there are circular marks around the device.Suggesting, it was attached and detached from a sleeve mating component.No device associated with this report was received for examination.Depuy synthes considers, the investigation closed at this time.Should additional information be received, the information will be reviewed.And the investigation may be re-opened as necessary.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.

• Brand Name: LPS FEM TO SLEEVE ADAPTER +10
• Common Device Name: LPS AND S-ROM : KNEE FEMORAL ACCESSORY
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15099306
• Report Number: 1818910-2022-13954
• Device Sequence Number: 4149454
• Product Code: MBH
• UDI-Device Identifier: 10603295078500
• UDI-Public: 10603295078500
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K071417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 07/25/2022

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 Model Number: 1987-06-010
• Device Catalogue Number: 198706010
• Device Lot Number: J6414R
• 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: 07/07/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2019
• 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: LPS DISTAL FEM COMP XSM RT (EX PKT); LPS FEM TO SLEEVE ADAPTER +10; LPS UNIV TIB HIN INS XSM 14MM; SROM*NRH REPL HINGE PIN/XSM/SM; UNIVERSAL FEM SLV DIS POR 31MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown