MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LPS UNIV TIB HIN INS XXSM 21MM; LPS AND S-ROM : KNEE TIBIAL INSERT

Model Number 1987-27-021

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 05/09/2023

Event Type  Injury  

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 Description

Following the dislocation of a massive lps tka, the surgeon noted during the revision that day that the insert was separated from its polyethylene part to its metal part.The surgeon wonders if this observation is not the cause of the dislocation of the prosthesis.Consequence: reoperation of the patient with change of the distal femur + segment + keel + insert.Doi: (b)(6) 2023.Dor: (b)(6) 2023.Unknown side.

Event Description

Additional information received indicated that when removing the dislocated implant, the surgeon noted that the insert was mismatched between its polyethylene part and its metallic reinforced part.The insert was removed.There was loosening of the femoral stem and replacement of the metal rotary hinge.There was no surgical delay.

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.

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.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was returned to depuy synthes for evaluation.Visual inspection and photograph review found the metal component partially disassociated from the poly component, which could have contributed to the dislocation event, however no fracture could be identified.The overall complaint can be confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.

• Brand Name: LPS UNIV TIB HIN INS XXSM 21MM
• Type of Device: LPS AND S-ROM : KNEE TIBIAL INSERT
• 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: 16945135
• MDR Text Key: 315364033
• Report Number: 1818910-2023-10402
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295079378
• UDI-Public: 10603295079378
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K091453
• 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: 05/17/2023

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
• Device Operator: Health Professional
• Device Model Number: 1987-27-021
• Device Catalogue Number: 198727021
• Device Lot Number: HY2398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 05/22/2023; 06/01/2023; 07/05/2023; 07/25/2023
• Supplement Dates FDA Received: 06/01/2023; 06/12/2023; 07/11/2023; 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CIMENT MV PALACOS 500MG GENTA 40G; LPS DISTAL FEM COMP XXSM LT; MBT REVISION CEM TIB TRAY SZ 3; UNKNOWN KNEE FEMORAL STEM
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male