MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 PFC SIG RPF INS SZ 5 10MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Catalog Number	951050
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Date of Event	03/26/2018
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
Total knee revision, (b)(6), (b)(6) 2018.Primary implant date: (b)(6) 2008.Revision was pain due to possible loosening of femoral implant as manifested by radio-translucent line around femur on x-ray.Patient presented with pain in left knee to surgeon a few months ago.Patient had a primary cemented pfc rpf in bilateral knees, however only symptomatic in the left.Upon x-ray, surgeon noted a radio-translucent line around the femur, possible indication of loosening.During revision, surgeon indicated that the femur was not loose, however still chose to revise the knee with a tc3/mbt stems and sleeves.Xrays available.Male patient initials: (b)(6), aged (b)(6) years, dob: (b)(6).(unknown (b)(4): no product code: pfc rpf: no lot #).(b)(4) representative was present at revision.Doi: (b)(6) 2008; dor: (b)(6) 2018; left knee.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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.

• Brand Name: PFC SIG RPF INS SZ 5 10MM
• Common Device Name: PFC SIGMA RP-F : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• MDR Report Key: 7521787
• Report Number: 1818910-2018-59841
• Device Sequence Number: 1176300
• Product Code: LPH
• UDI-Device Identifier: 10603295230458
• UDI-Public: 10603295230458
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K954811
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2018

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: 951050
• Device Lot Number: C13LR4
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 05/17/2018
• Supplement Report FDA Received Date: 09/10/2018
• 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: 73 YR