MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI TIB TRAY SZ5 RMLL; EARLY INTERVENTION : KNEE TIBIAL TRAY

Model Number 1024-52-500

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

Patient Problems Pain (1994); No Code Available (3191); Joint Laxity (4526); Insufficient Information (4580)

Event Date 03/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: patient.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The patient felt that the partial knee replacement failed him by coming out of place and underwent a revision procedure on (b)(6) 2019.Original procedure was on (b)(6) 2018.Doi: (b)(6) 2018; dor: (b)(6) 2019; affected side: unknown knee.

Manufacturer Narrative

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 been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy as not 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.Product complaint # : (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot : null.Device history batch : null.Device history review : null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch 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.H10 additional narrative:  added: d4, g4, h4, h5, h8 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: d1, d2a, d2b, d10 re-captured h6 (clinical, impact and medical device problem codes).

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.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.

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.Corrected: b3, d6a, d6b, h6 health effect - clinical code & medical device problem code.

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 (b)(6) 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 TIB TRAY SZ5 RMLL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL TRAY
• 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 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9929379
• MDR Text Key: 186742106
• Report Number: 1818910-2020-10270
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 10603295002413
• UDI-Public: 10603295002413
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1024-52-500
• Device Catalogue Number: 102452500
• Device Lot Number: H54815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2017
• 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; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE FEMORAL; UNKNOWN KNEE PATELLA; UNKNOWN KNEE PATELLA; UNKNOWN KNEE TIBIAL INSERT
• Patient Outcome(s): Required Intervention