MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA HP UNI INS SZ5 8MM RM/LL; EARLY INTERVENTION : KNEE TIBIAL INSERT

Model Number 1024-54-508

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 05/29/2020

Event Type  Injury  

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 Description

Procedure: sigma partial knee replacement.I was present at the original case which was done on 28/05.When we were about to implant the definitive tibial insert (7mm) the scrub nurse accidentally threw it in the rubbish bin.We only had one set of implants on site, so we had no option but to put the 8mm in and then close the wound.I spoke to the surgeon after the case and he said that the knee was prepared and balanced for a 7mm and the 8mm was too tight, and that he would need to swap the tibial insert out tomorrow.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications.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.Corrective action was not indicated.

• Brand Name: SIGMA HP UNI INS SZ5 8MM RM/LL
• 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: 10146926
• MDR Text Key: 194939948
• Report Number: 1818910-2020-13698
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 10603295002949
• UDI-Public: 10603295002949
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1024-54-508
• Device Catalogue Number: 102454508
• Device Lot Number: J3062N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SIGMA HP UNI INS SZ5 8MM RM/LL.; SIGMA HP UNI INS SZ5 8MM RM/LL
• Patient Outcome(s): Required Intervention