MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SIG PS CEM FEM W/LUGS LT SZ4N; SIGMA KNEE PRIMARY : KNEE FEMORAL

Catalog Number	196069500
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: evaluation of the returned device confirms the reported damage.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.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
Der states femur implant was severely scratched and not usable, came from original packaging damaged.A second femur implant was opened.The damaged implant is being returned.No surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: evaluation of the returned device confirms the reported damage.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 : product code 196069500, lot number c59934).Device history review:a device history record review was conducted and it was confirmed that it was manufactured per specification and did not reveal any manufacturing related anomalies or deviations.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: SIG PS CEM FEM W/LUGS LT SZ4N
• 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: 8190237
• Report Number: 1818910-2018-79021
• Device Sequence Number: 1900967
• Product Code: JWH
• UDI-Device Identifier: 10603295075356
• UDI-Public: 10603295075356
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K073529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2018

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: 196069500
• Device Lot Number: C59934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 12/23/2018
• Patient Sequence Number: 1
• Patient Age: 64 YR