MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB GVF INS 2 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-21-010
Medical Device Problem Codes	Naturally Worn (2988); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Ambulation or Postural Difficulties (2544); Joint Laxity (4526)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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
(b)(6) 2022 patient came to (b)(6) seeking for help due to unstable right knee.Patient had a total knee replacement (bilateral) back in (b)(6) 2018 at (b)(6) with the same surgeon.System used was pfc implants.Surgeon suspected is the implant insert (polyethylene) issue.Hence, contacted me and arranged for a change of insert procedure the next day.(b)(6) 2022 surgeon able to confirm it is the issue of implant insert after exposing the right knee and hence, did a change of insert procedure.Surgeon commented pfc implants supposed to last at least 20yrs as per the clinical papers.Patient had the bilateral tkr procedure only 4yrs ago.Doi: (b)(6) 2018; dor: (b)(6) 2022; right knee.
Event or Problem Description
Additional information received indicated that there was sudden anterior subluxation.Stability was related to polyethylene wear.
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 received for examination.Photographic review along with visual examination of the part denoted a remarkable worn condition throughout the part which is consistent with localized wear at one of the condyle's bearing area in consequence to possible implant and/or patient loading into this area.Also it was observed that due to worn condition at the edge, a portion of the poly implant was separated from the rest of the part.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will 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.Device history review: a manufacturing record evaluation was performed for the finished device (product code/lot) product and lot numbers, and no non-conformances were identified.
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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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.

• Brand Name: SIGMA STAB GVF INS 2 10MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJM (SUZHOU) LTD. 3006356043; no.299 changyang st; suzhou industrial park; suzhou jiangsu 21512 -6; CH 21512-6
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13840668
• Report Number: 1818910-2022-05088
• Device Sequence Number: 4590280
• Product Code: JWH
• UDI-Device Identifier: 10603295063933
• UDI-Public: 10603295063933
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup,Followup
• Report Date (Section B): 03/21/2022

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: 1581-21-010
• Device Catalogue Number: 158121010
• Device Lot Number: D17093885
• 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: 03/04/2022
• Supplement Date Received by Manufacturer: 03/30/2022; 04/22/2022; 05/13/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 04/12/2022; 04/26/2022; 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female