MAUDE Adverse Event Report: DEPUY RAYNHAM 1219655 LPS UNIV TIB HIN INS XXSM 16MM; KNEE TIBIAL BEARING/INSERT

Catalog Number	198727016
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	08/01/2017
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
Der states that the patient dislocated lps femur prosthesis tka.The insert was still engaged with the femur, however, the post of the insert was dislocated from the mbt revision tibial tray.Patient was brought to surgery and the insert or tka was reduced.Surgeon chose not to change any of the components.Patient was a poor reporter and does not recall how or when the knee dislocated.
Additional Manufacturer Narrative
No device associated with this report was received for examination.A worldwide complaint database search found no other reported incident(s) against the provided product/lot combination(s) since release for distribution.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: LPS UNIV TIB HIN INS XXSM 16MM
• Common Device Name: KNEE TIBIAL BEARING/INSERT
• Manufacturer (Section D): DEPUY RAYNHAM 1219655; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6833743
• Report Number: 1818910-2017-23809
• Device Sequence Number: 60687
• Product Code: NJL
• UDI-Device Identifier: 10603295079354
• UDI-Public: 10603295079354
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 08/01/2017

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: 198727016
• Device Lot Number: 513208
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 09/07/2017
• 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: 79 YR