MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD XLK INS 4 12.5MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-14-112
Medical Device Problem Codes	Difficult to Insert (1316); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that pfc sigma tibial insert fixed bearing curved 4, 12.5 mm was faulty, with the lip at the bottom of the insert damaged.There was surgical delay of 2 to 3 minutes.Doe: (b)(6) 2023.Affected side: unknown knee.
Event or Problem Description
Additional information received: a.What is the affected side involved in this event? left or right? this involved the right knee.B.Can you please clarify what you mean by "damaged" or "faulty"? was it worn, cracked, broken into pieces, bent, stripped, cross-threaded, or any device interaction? a lip of the fixed bearing insert was bent so that it would not fit into the fixed bearing tibial tray.C.Did the event happen during primary or revision surgery? this event occurred during primary knee replacement surgery.D.Was there any adverse consequences that affected the patient because of the reported surgical delay? there were no adverse consequences or symptoms due to the delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.  device history lot : a manufacturing record evaluation (nc search) was performed for the finished device 158114112, lot 9702559 and no non-conformances / manufacturing irregularities were identified.

• Brand Name: SIGMA CRVD XLK INS 4 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): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16252836
• Report Number: 1818910-2023-02187
• Device Sequence Number: 5351064
• Product Code: JWH
• UDI-Device Identifier: 10603295063520
• UDI-Public: 10603295063520
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1581-14-112
• Device Catalogue Number: 158114112
• Device Lot Number: 9702559
• 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: 01/16/2023
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male