MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB XLK INS 5 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Model Number	1581-25-108
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/06/2022
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
It was reported that the implant was not fitted as it should, so he requested the opening of another unit of the same code.5 minute delay.
Event or Problem Description
Additional information received.A.Please clarify what you meant by implant was not fitted as it should.Was the implant difficult to insert into the tibial tray? -the insert could not be inserted into the tibia, so it was necessary to use another implant.B.Was there any adverse consequences that affected the patient because of the reported event? -there is no adverse effect on the patient.
Additional 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.H10 additional narrative: added: b5, d4 (lot), d9, h4 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected:.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary: the device associated with this report was received for examination.After physical review of the piece, it was not possible to confirm the reported allegation since the complaint device does not shows anomalies or defects that could be contribute to the alleged failure, therefore, the complaint cannot be confirmed.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: SIGMA STAB XLK INS 5 8MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14547210
• Report Number: 1818910-2022-09798
• Device Sequence Number: 17382750
• Product Code: JWH
• UDI-Device Identifier: 10603295064657
• UDI-Public: 10603295064657
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/31/2022

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: 1581-25-108
• Device Catalogue Number: 158125108
• Device Lot Number: 9484051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 06/08/2022; 08/05/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 06/13/2022; 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown