MAUDE Adverse Event Report: ZIMMER, INC. PERSONA TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 10 MM; INSTRUMENT, KNEE

Catalog Number 42527900600

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer has returned the product and it is awaiting evaluation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

The persona knee instrument was returned via worn instrument return program.It was reported after reviewing the returned device that it is missing the bearing and spring components.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Product was returned and examination of the returned parts determined that there was signs of repeated use.Ball bearings and associated springs were not returned, thus confirming missing components.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no were trends identified.It was determined that this device was manufactured prior to this design change.The root cause of the reported issue is attributed to design deficiency.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 TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 10 MM
• Type of Device: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6635158
• MDR Text Key: 77453931
• Report Number: 0001822565-2017-03991
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42527900600
• Device Lot Number: 62732166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: 11/16/2017
• Supplement Dates FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: Z-1052-2015
• Patient Sequence Number: 1