MAUDE Adverse Event Report: ENCORE MEDICAL L.P. LATERAL PIVOT INSERT; INSERT, STD., PRIMARY, SIZE6 11MM CM

Model Number	385-11-506
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	05/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reason for this revision surgery was due to poly wear.The actual length of in-vivo for the item listed is unknown as the original surgery date was not provided or could be established.The healthcare professional indicated there was a significant adverse event to the patient.There was no delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records (dhr) was not conducted since the item and or lot number(s) was not provided or determined during the complaint evaluation.Given the limited information, a search for an invoice of the previous surgery produced no results.Customer complaint history of the reported device(s) showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a revision surgery due to poly wear.The length of in-vivo service is unknown since an original surgery date was not provided or could be established.Should addition information become available this complaint shall be re-opened and a further evaluation well be conducted.This complaint will be closed with the lot number(s) unknown.Should additional information become available at a later date, the complaint will be updated.No further action is deemed necessary.
Event or Problem Description
Revision surgery - due to the patient presenting at surgeons office with knee discomfort and instability.Upon xray, surgeon determined there was poly wear.

• Brand Name: LATERAL PIVOT INSERT
• Common Device Name: INSERT, STD., PRIMARY, SIZE6 11MM CM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8724735
• Report Number: 1644408-2019-00589
• Device Sequence Number: 1684616
• Product Code: JWH
• UDI-Device Identifier: 00888912117852
• UDI-Public: (01)00888912117852
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K000590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2019

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 Model Number: 385-11-506
• Device Catalogue Number: 385-11-506
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 130-03-038, LOT UNKNOWN
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 50 YR