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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Loss of Range of Motion (2032); Scarring (2061); Not Applicable (3189)
Date of Event	07/06/2018
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
Patient was doing extremely well until approximately (b)(6) 2018, where he reported doing a "minor extension action when pushing a trolley.He had immediate onset of pain.He is unable to walk up and down stairs without pain and an able to sit for prolonged periods of time.He is aware of a clicking and catching sensation.X rays appear to show that the components are well fixed and that there may be a slightly oblique resection of the patella when the patella was resurfaced at time of primary surgery.A decision has been make to open the knee and remove the existing patella, recut the patella bone and then resurface the patella.On opening the knee all components were well fixed.Scar tissue surrounded the patella button.The knee was slightly loose through the range of motion, the poly was removed and up sized to a thicker 12.5mm insert.Patella was removed and repositioned.A new 41mm patella was inserted.
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: 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: 7742027
• Report Number: 1818910-2018-65608
• Device Sequence Number: 1405435
• Product Code: NJL
• UDI-Device Identifier: 10603295230458
• UDI-Public: 10603295230458
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2018

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: BF02244541
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 09/18/2018
• 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: 70 YR