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

Catalog Number	196030400
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	01/10/2019
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
Patient was revised to address loosening of the femoral and tibial component at cement to implant interface.Depuy cement was used.It was also reported that the patient was having pain and instability during walking.
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: no device associated with this report was received for examination.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.Device history lot: null.Device history batch: null.Device history review: null.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 RT
• Common Device Name: SIGMA KNEE PRIMARY : KNEE FEMORAL
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8294472
• Report Number: 1818910-2019-82933
• Device Sequence Number: 1204146
• Product Code: JWH
• UDI-Device Identifier: 10603295074960
• UDI-Public: 10603295074960
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K082500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

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: 196030400
• Device Lot Number: 3254419
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2019
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 02/11/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR