MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ1 8MM RM/LL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number	1024-54-108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/24/2021
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
Sigma partial knee revision.
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.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device does not confirm the reported event and found no defects present.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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 evaluation (mre) was not performed.

• Brand Name: SIGMA HP UNI INS SZ1 8MM RM/LL
• Common Device Name: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11453962
• Report Number: 1818910-2021-04826
• Device Sequence Number: 3818036
• Product Code: HRY
• UDI-Device Identifier: 10603295002741
• UDI-Public: 10603295002741
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K070267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2021

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 Model Number: 1024-54-108
• Device Catalogue Number: 102454108
• Device Lot Number: J0816J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: 02/25/2021
• Supplement Date Received by Manufacturer: 04/08/2021; 04/29/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 04/15/2021; 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PALACOS CEMENT; SIGMA HP UNI FEMORAL SZ2 RM/LL; SIGMA HP UNI INS SZ1 8MM RM/LL; SIGMA HP UNI TIB TRAY SZ1 RMLL; PALACOS CEMENT; SIGMA HP UNI FEMORAL SZ2 RM/LL; SIGMA HP UNI INS SZ1 8MM RM/LL; SIGMA HP UNI TIB TRAY SZ1 RMLL
• Outcome Attributed to Adverse Event: Required Intervention