MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC*SIGMA C/R NPOR FEM LT SZ5; SIGMA KNEE PRIMARY : KNEE FEMORAL

Model Number	96-0005
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/08/2021
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
Patient had loosening on both the tibial and femoral components.Patient had a primary sigma fb cr construct in.Both had too much wear (been in patient ~20 yrs) and cement to make out exact product # and lot # but thought to be a sz 5 femur and 4 or 5 tibia with a 10 mm insert.Patella was left in and not revised.Doi: unknown.Dor: unknown.Unknown side.
Additional Manufacturer Narrative
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 : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.
Event or Problem Description
Additional information received indicated that the loosening was at the femoral and tibial impants to the bone interfaces, likely due to subsidence or motion of the tibial implant.There was no delay in surgery.Affected side was the left side.
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.

• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12672444
• Report Number: 1818910-2021-23123
• Device Sequence Number: 14631243
• Product Code: JWH
• UDI-Device Identifier: 10603295231974
• UDI-Public: 10603295231974
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K943462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 96-0005
• Device Catalogue Number: 960005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 10/15/2021; 11/15/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 10/29/2021; 11/18/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CEMENT MFG AND PRODUCT NAME UNKNOWN.; PFC*SIGMA C/R NPOR FEM LT SZ5.; UNK KNEE TIBIAL INSERT SIGMA.; UNK KNEE TIBIAL TRAY SIGMA.; PFC*SIGMA C/R NPOR FEM LT SZ5; UNK KNEE TIBIAL INSERT SIGMA; UNK KNEE TIBIAL TRAY SIGMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown