MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SIGMA STAB XLK INS 2.5 8MM; SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT

Catalog Number	158122108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	10/31/2017
Type of Reportable Event	Serious Injury
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
Adverse event received for surgical site pain and limb swelling.
Additional Manufacturer Narrative
(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.Corrective action was not indicated.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, will be filed as appropriate.
Additional Manufacturer Narrative
Narrative when creating a correction medwatch if a depuy product is not involved in the reported event: this product was reported in error.No patient death, serious injury or evidence of reportable product malfunction occurred.Depuy considers the investigation closed at this time.Should any additional information be received to change the outcome of the performed investigation, the complaint will be re-opened.

• Brand Name: SIGMA STAB XLK INS 2.5 8MM
• Common Device Name: SIGMA KNEE PRIMARY : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8239851
• Report Number: 1818910-2019-80589
• Device Sequence Number: 19380775
• Product Code: JWH
• UDI-Device Identifier: 10603295064169
• UDI-Public: 10603295064169
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040166
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 158122108
• Device Lot Number: 8344214
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 01/17/2019; 02/05/2019
• Initial Report FDA Received Date: 01/11/2019
• Supplement Report FDA Received Date: 01/17/2019; 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 66