MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. PERSONA ARTICULAR SURFACE (UC) FIXED BEARING LEFT 12MM; PROSTHESIS, KNEE

Catalog Number 42512200412

Device Problem Unstable (1667)

Patient Problem Pain (1994)

Event Date 06/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation due to hospital retaining device.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported following a knee arthroplasty, the patient was revised due to pain and instability.The congruent bearing was removed and replaced.Attempts have been made and additional information on the reported event is unavailable.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Concomitant medical product- femur cemented cruciate retaining (cr) narrow left size 5 catalog#: 42502005801 lot#: 63320862, tibia cemented 5 degree stemmed left size d catalog#: 42532006701 lot#: 63318851, all-poly patella cemented 29 mm diameter catalog#:42540200029 lot#: 63135525.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found review of the complaint history determined that no further action is required as no were trends identified.Per the packaging insert, pain, dislocation and/or joint instability, and loosening of the prosthetic knee components are listed as potential adverse effects of the procedure.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PERSONA ARTICULAR SURFACE (UC) FIXED BEARING LEFT 12MM
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6695178
• MDR Text Key: 79352395
• Report Number: 0002648920-2017-00439
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 42512200412
• Device Lot Number: 63070867
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR