MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD GVF INS 4 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-14-010
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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
Surgeon performing total knee replacement could not get the below tibial insert to lock into the tibial tray.A second insert was opened and successfully locked in to the tibial base plate.The surgeon feels the locking tabs on the insert may have been substandard, stopping the locking mechanism.This occurred during surgery.Delay to surgery 6-7mins, patient outcome successful surgery, no harm was caused to the patient.
Additional Manufacturer Narrative
Product complaint # : pc-(b)(4).Investigation summary : the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.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 : the dhr review revealed the finished device 158114010/ d20031705, was manufactured on 16-mar-2020.(b)(4) parts were manufactured per specification and all raw materials met specification, and no non-conformances were identified.

• Brand Name: SIGMA CRVD GVF INS 4 10MM
• 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: 11827028
• Report Number: 1818910-2021-10360
• Device Sequence Number: 14556563
• Product Code: JWH
• UDI-Device Identifier: 10603295063452
• UDI-Public: 10603295063452
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033272
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 04/30/2021

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: 1581-14-010
• Device Catalogue Number: 158114010
• Device Lot Number: D20031705
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 07/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR