MAUDE Adverse Event Report: DEPUY IRELAND 9616671 PFC*SIGMA C/S NPOR FEM LT SZ 4; KNEE FEMORAL COMPONENT

Catalog Number	960044
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The patient was revised to address knee pain.Patient has reported being unable to walk for more than 50 meters before needing to rest their knee, due to pain.It was also reported that on examination it appears that the knee is imbalanced with the lateral side opening up to 7mm in extension and 4 mm in flexion and the patella was overhanging on the medial side and appeared undersized.
Additional Manufacturer Narrative
The patient was revised to address knee pain.Patient has reported being unable to walk for more than 50 meters before needing to rest their knee, due to pain.It was also reported that on examination it appears that the knee is imbalanced with the lateral side opening up to 7mm in extension and 4 mm in flexion and the patella was overhanging on the medial side and appeared undersized.The reported event has been evaluated and will be monitored.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.

• Common Device Name: KNEE FEMORAL COMPONENT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 6954598
• Report Number: 1818910-2017-26635
• Device Sequence Number: 13675844
• Product Code: JWH
• UDI-Device Identifier: 10603295232247
• UDI-Public: 10603295232247
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K950010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2017

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: 960044
• Device Lot Number: 7826984
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 11/11/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR