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

Model Number	1581-24-112
Medical Device Problem Codes	Difficult to Insert (1316); Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Total knee replacement: (b)(6) 2019.When tibial insert was inserted it was noted by surgeon that it failed to engage.No extreme force used.Dr states the poly was damaged at the front flap left side requested a replacement.On looking at the poly noticed the front left flap was bent.It has not broken off but appears to have a slight wobble.He states this has happened before.5 minutes delay.Action taken to manage : poly removed and another one put in its place.Male patient initials: (b)(6), dob: (b)(6).
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.H6 patient code: no code available (3191) used to capture the prolonged surgery.

• Brand Name: SIGMA STAB 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
• MDR Report Key: 8951063
• Report Number: 1818910-2019-102679
• Device Sequence Number: 14071212
• Product Code: JWH
• UDI-Device Identifier: 10603295064503
• UDI-Public: 10603295064503
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2019

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: No Information
• Device Model Number: 1581-24-112
• Device Catalogue Number: 158124112
• Device Lot Number: 8021049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 11/07/2019; 07/31/2020
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 11/11/2019; 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR