MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC SIGMA TIB TRAY CEM SZ3; SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY

Model Number	86-6023
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Hcp reported to bfarm: "knee tep right side (b)(6) 2001 in neustadt because of varus gonarthrosis.Since the beginning of the year 2022 there is again pain in the right knee joint, since then also increasing bow-leg deformity.The patient is able to walk 200 meters without any aids under pain.Climbing stairs is laborious.Obese.Bmi 30.Knee tep left (b)(6) 2001.Radiological pe wear and loosening of tibia.Replacement surgery right knee on (b)(6) 2022.".
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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 medwatch, a follow-up medwatch will be filed as appropriate.The device catalog number is unknown; therefore, udi is unavailable.
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) 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.Updated the concomitant product unk knee tibial tray to unk knee tibial insert.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was returned to depuy synthes for evaluation.The photo investigation and visual examination confirmed the reported allegation.Polished-like appearance and/or burnishing was found on the bottom surface of the device, which is indicative of micromotion between the cement and the implant.Burnishing was also found on the top surface, which indicates there was movement between the tibial insert and tibial tray, however no sufficient evidence of disassociation was found.Additionally, heavy gross wear was found on one of the condyles on the device.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : 1) quantity manufactured: (b)(4).2) date of manufacture: 18-may-2001.3) any anomalies or deviations identified in dhr: there were no non-conformances.Associated with this lot.4) expiry date: may -2011.5) ifu reference: not available.Device history review : 1) quantity manufactured: (b)(4).2) date of manufacture: 18-may-2001 3) any anomalies or deviations identified in dhr: there were no non-conformances associated with this lot.4) expiry date: may -2011 5) ifu reference: not available.

• Brand Name: PFC SIGMA TIB TRAY CEM SZ3
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL TRAY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr; warsaw, IN 46580 ; 3035526892
• MDR Report Key: 15339426
• Report Number: 1818910-2022-17060
• Device Sequence Number: 20454495
• Product Code: JWH
• UDI-Device Identifier: 10603295216780
• UDI-Public: 10603295216780
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K884796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 05/18/2011
• Device Model Number: 86-6023
• Device Catalogue Number: 866023
• Device Lot Number: 914759
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 09/28/2022; 11/11/2022; 03/03/2023
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 10/04/2022; 11/17/2022; 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2001
• Is the Device Labeled for Single Use? (Y/N): No
• 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: PFC SIGMA TIB TRAY CEM SZ3; UNK ATTUNE KNEE IMPLANT; UNK ATTUNE KNEE IMPLANT; UNK KNEE TIBIAL TRAY; UNKNOWN KNEE TIBIAL INSERT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female