MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMARP STB TB IN 2.5 12.5; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	96-2122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Joint Laxity (4526)
Date of Event	05/04/2021
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
The patient was revised to address pain and instability.The surgeon wanted to do a poly exchange.He felt that the patient needed a thicker insert.He removed the poly, trialed a thicker insert trial and felt that it gave the patient the stability that she needed.He also found some cement debris that had been left from the previous surgeon and thought that it may have contributed to some of the patient's complaints of pain/stability.Doi: (b)(6) 2018, dor: (b)(6) 2021, left knee.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.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.
Event or Problem Description
Additional information was received indicated the following: question: 1.The event description indicated that the surgeon found some cement debris that had been left from the previous surgeon.Was the cement product manufactured by depuy? if yes, please provide the quantity, part and lot numbers of the cement.2.Was instability related to polyethylene wear? 3.Was there any reported malposition of components that led to the instability? 4.Were any components undersized on the primary surgery that led to the instability? 5.Was the femur or tibia excessively resected/joint line raised during the primary surgery that led to the instability.Response; 1.Unknown, 2.No, 3.No, 4.No, 5.No.
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.

• Brand Name: PFC SIGMARP STB TB IN 2.5 12.5
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11837884
• Report Number: 1818910-2021-10499
• Device Sequence Number: 3789174
• Product Code: NJL
• UDI-Device Identifier: 10603295241188
• UDI-Public: 10603295241188
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2021

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: 96-2122
• Device Catalogue Number: 962122
• Device Lot Number: 8278848
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 05/14/2021; 06/29/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 05/31/2021; 06/30/2021
• 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: BONE CEMENT(MFG AND PRODUCT NAME UNKNOWN).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR