MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD. 8010379 PFC SIG RPF INS SZ 3 15MM; PFC SIGMA RP-F : KNEE TIBIAL INSERT

Catalog Number	951032
Medical Device Problem Codes	Naturally Worn (2988); Unintended Movement (3026)
Health Effect - Clinical Codes	Joint Dislocation (2374); No Code Available (3191)
Date of Event	06/10/2019
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.(b)(4).
Event or Problem Description
The primary surgery was performed on (b)(6) 2011 for the patient has parkinson's disease.It was reported that dislocation occurred after 2 weeks from the primary surgery.After that, dislocation had occurred 1-2 times a month and frequent dislocation had recurred recently.The femur was dislocated to the anterior when the patient stood up, it was confirmed that there was a suspected the tibial insert spinout at x-ray.Thus, the revision surgery was performed by replacing the tibial insert (p/n: 951032) to one size bigger 17.5mm tibial insert on (b)(6) 2019.The surgery was completed without a surgical delay.It was confirmed that wear of the tibial insert anterior lip and the tibial insert post.Possible cause: insufficient removal of tissue such as outer meniscus, insufficient gap management at the primary surgery (because the extension gap was loose than flexion gap).No further information is available.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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 was received.Root cause undetermined.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: PFC SIG RPF INS SZ 3 15MM
• Common Device Name: PFC SIGMA RP-F : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD. 8010379; st. anthony's rd; leeds LS11 8 DT; UK LS11 8 DT
• MDR Report Key: 8743967
• Report Number: 1818910-2019-97066
• Device Sequence Number: 2371913
• Product Code: NJL
• UDI-Device Identifier: 10603295230397
• UDI-Public: 10603295230397
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P830055
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2019

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: 951032
• Device Lot Number: CN7HT4000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 08/28/2019
• 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