MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIGMA PS CEM FEM SZ2 R; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number	196050200
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that (b)(4) melwatch will be filed as appropriate.Follow-up medwatch will be filed as appropriate.
Event or Problem Description
Customer sent implant to dot to have it coated with tini.At incoming inspection dot identified some scratches on the implant and refused it to undergo the tini coating-process.No surgery delay, no adverse consequences for patient reported.
Additional Manufacturer Narrative
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.Product complaint # = > (b)(4).Investigation summary = > a review of the returned product did confirm that the product had one visible scratch and two impacts.However when the scratch and impacts were compared with the inspection requirements it was found that they were acceptable to the procedure.All in process inspections conducted and passed.Based on this, it can be concluded that the part was manufactured according to the required specifications.Based on this review, no further action is required at this time, however further occurrences of this failure mode will be monitored.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SIGMA PS CEM FEM SZ2 R
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8799297
• Report Number: 1818910-2019-98568
• Device Sequence Number: 13508233
• Product Code: JWH
• UDI-Device Identifier: 10603295075110
• UDI-Public: 10603295075110
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K073529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2019

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: Health Professional
• Device Catalogue Number: 196050200
• Device Lot Number: 9038326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1