MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ5 7MM RM/LL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number 1024-54-507

Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Joint Laxity (4526); Insufficient Information (4580)

Event Date 03/02/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Review of the photographic and x-ray evidence found nothing indicative of a device nonconformance that could have contributed to the reported event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 Description

It was reported from a california department of public health, food and drug, received a complaint in october 2019 and emailed our firm (b)(6) 2019, but she never received a reply.The complainant had a partial knee replacement with a depuy sigma uka product installed on (b)(6) 2018.The complainant stated he had completed his rehabilitation.While the complainant was walking upstairs, the partial knee replacement failed him by ¿coming out of place¿.Complainant stated he had received permission by his doctor to walk upstairs.The revision surgery was (b)(6) 2019.Complainant believes the medical device was defective.Doi: (b)(6) 2018 - dor: (b)(6) 2019 (unk knee).

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.

Event Description

On (b)(6) 2018, the patient had a right partial knee replacement.On (b)(6) 2019 the patient had a right partial knee revision.The patient reports pain, and it was noted that there were two dislodgements of the insert.It should be noted that the there were no time frames listed for the patient harms.There was also no mention of manufacturer of implants.Radiographs from 04/01/2019, we were reported to show a partial knee arthroplasty with what appears to be a dislodged polyethylene and there is also lateral patellar tracking and lateral patellar tilt.¿there appears to be an undersized tibial component¿.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.Review of the photographic and x-ray evidence was able to confirm the complaint.It can be observed that the femoral component and the tibial tray are having contact, this is indicative of a disassociation event of the tibial insert from the tibial tray.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records (mre) was not performed.

• Brand Name: SIGMA HP UNI INS SZ5 7MM RM/LL
• Type of Device: EARLY INTERVENTION : 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: 16597882
• MDR Text Key: 311926910
• Report Number: 1818910-2023-06460
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 10603295002932
• UDI-Public: 10603295002932
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1024-54-507
• Device Catalogue Number: 102454507
• Device Lot Number: J03C87
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• 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: SIGMA HP UNI INS SZ5 7MM RM/LL.; SIGMA HP UNI TIB TRAY SZ5 RMLL.; UNKNOWN KNEE FEMORAL.; UNKNOWN KNEE PATELLA.
• Patient Outcome(s): Required Intervention