MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 SIGMA CR150 CEM SZ 4 LT; KNEE FEMORAL

Catalog Number	196020400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Foreign Body Reaction (1868)
Date of Event	12/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
The patient was revised to address allergy to nickel and loosening of unknown component at the cement to implant interface.Depuy cement was used.Doi: (b)(6) 2010.Dor: (b)(6) 2017.Left knee.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary no device associated with this report was received for examination.Depuy synthes considers the investigation closed.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 will be filed as appropriate.

• Brand Name: SIGMA CR150 CEM SZ 4 LT
• Common Device Name: KNEE FEMORAL
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7174862
• Report Number: 1818910-2018-50603
• Device Sequence Number: 1863280
• Product Code: JWH
• UDI-Device Identifier: 10603295074878
• UDI-Public: 10603295074878
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K082500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2017

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: 196020400
• Device Lot Number: 2843728
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 09/25/2018
• 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: 60 YR
• Patient Weight: 90