MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM - ARTICULAR SURFACE 10 MM HEIGHT; PROSTHESIS, KNEE

Catalog Number 42522000510

Device Problem Insufficient Information (3190)

Patient Problems Nerve Damage (1979); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products ¿ persona femur size 10 catalog 42502606802 lot 62703557; persona tibia size f catalog 2532007502 lot 63359529.(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the implants remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 1822565-2017-01775 and 3007963827-2017-00031.

Event Description

It was reported that a patient underwent a right total knee arthroplasty which has subsequently disturbed the peroneal nerve function causing numbness of the lateral foot.There was no indication that the patient will be revised.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record 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 trends were identified.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: ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM - ARTICULAR SURFACE 10 MM HEIGHT
• 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: 6414749
• MDR Text Key: 70257547
• Report Number: 0002648920-2017-00200
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 42522000510
• Device Lot Number: 63315264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2016
• 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): Disability
• Patient Weight: 111