MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD GVF INS 3 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158113012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Joint Laxity (4526)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Article entitled ¿3d polyethylene wear analysis after primary cruciate-retaining tka failure using optical scanning and cad models references¿ written by matej valic, vesna leva¿ic, ingrid milo¿ev, mateja blas, eva podov¿ovnik, jaka koren, and rihard treb¿e was reviewed.Our purpose was to identify (a) whether volumetric wear (adjusted for time in-situ) significantly differ among groups of common causes of tka failure, (b) whether there is a characteristic wear distribution pattern for a common cause of tka failure, and (c) whether nominal insert size (small vs large) and components size ratio (femur-to-insert) influence on volumetric wear rates.The study included patients that had been implanted with a sigma tka (cemented tibial tray and porous coated femoral component).Within the patient that met the criteria, there were noted to be 86 revision cases due to failure (no mention of why).59/86 tibial inserts were retrieved.2 of the 59 inserts exhibited inexplicable abnormal type of damage and were excluded from the final analysis.Final cohort included 57 inserts.There was no mention of cement mfg or patella implants.Results: 86 revisions.Only 5 patients had a single detected causes, while the remaining had 2-3 detected causes.35 cases of infection (13 of the 35 cases were noted to have loosening as well), 18 cases of osteolysis and loosening (unknown device), 6 cases of osteolysis, 28 cases of joint malignment or component malpositioning, 12 cases of instability, 10 cases with ligament insufficiency, and 3 cases for other isolated causes.Volumetric and linear wear noted on the 57 liners.2 liners excluded from analysis are pictured in figure 5 ¿ show signs of wear.
Additional Manufacturer Narrative
Product complaint #(b)(4).The size of the article is too large to attach/submit with the 3500a submission.The citation of the article has been provided below: article entitled ¿3d polyethylene wear analysis after primary cruciate-retaining tka failure using optical scanning and cad models references¿ written by matej valic, vesna leva¿ic, ingrid milo¿ev, mateja blas, eva podov¿ovnik, jaka koren, and rihard treb¿e was reviewed.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: the device lot number is unknown, therefore a¿device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

• Brand Name: SIGMA CRVD GVF INS 3 12.5MM
• 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): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19174339
• Report Number: 1818910-2024-08985
• Device Sequence Number: 7304322
• Product Code: JWH
• UDI-Device Identifier: 10603295063346
• UDI-Public: 10603295063346
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 158113012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown