MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ2 7MM LM/RL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number 1024-53-207

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  malfunction  

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 Description

Patient was revised due to tibial insert wouldn't seat in the tibial tray.Doi: unknown dor: (b)(6) 2021 left knee.

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.B1 (adverse event) and b2 should not have been checked since there was no reported patient consequence.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: examination of the returned device found no evidence confirming the reported event.The investigation found no evidence of product malfunction or product error and the need for corrective action was not indicated.Depuy synthese 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.The investigation found no evidence of product error as a contributing factor to the reported event and the need for corrective action was not indicated.Device history lot: the material records of three separate batches (j56h36, j54c79, and j54c78) were reviewed for finished goods lot j6286p.Review of all three batch records revealed no anomalies or deviations.

• Brand Name: SIGMA HP UNI INS SZ2 7MM LM/RL
• Type of Device: EARLY INTERVENTION : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12063788
• MDR Text Key: 263393755
• Report Number: 1818910-2021-13552
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 10603295002482
• UDI-Public: 10603295002482
• Combination Product (y/n): N
• PMA/PMN Number: K070267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2021

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
• Device Operator: Health Professional
• Device Model Number: 1024-53-207
• Device Catalogue Number: 102453207
• Device Lot Number: J6286P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 07/01/2021; 08/06/2021
• Supplement Dates FDA Received: 07/12/2021; 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR