MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA CRVD XLK INS 3 10MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-13-110
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
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
It was reported that the insert did not seat fully into the tibial tray.The doctor exchanged for a new insert and it seated fully.The doctor felt that the soft tissue probably held the insert from seating fully.
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 : product code 158113110, work order (b)(4) was manufactured on 19-april-2021.22 parts were manufactured per specification and all raw materials met specification.Scrap: there was no scrap associated with this lot reprocessing: there was no mrr associated with this lot non-conformance: there was no non-conformances associated with this lot.

• Brand Name: SIGMA CRVD XLK INS 3 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: 12211111
• Report Number: 1818910-2021-15734
• Device Sequence Number: 4672321
• Product Code: JWH
• UDI-Device Identifier: 10603295063391
• UDI-Public: 10603295063391
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 06/30/2021

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: 1581-13-110
• Device Catalogue Number: 158113110
• Device Lot Number: 9746702
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 09/08/2021
• 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: SIGMA CRVD XLK INS 3 10MM; UNKNOWN BONE CEMENT; SIGMA CRVD XLK INS 3 10MM; UNKNOWN BONE CEMENT
• Patient Age: 76 YR