MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED; KNEE, PROSTHESIS

Catalog Number 42512401011

Device Problems Pitted (1460); Naturally Worn (2988); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Date 05/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and 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: 0001822565-2018-02979, 3007963827-2018-00090.Concomitant medical products: cat: 42-5570-001-14 psn tpr st 14 x +30 mm lot: 63970318, cat: 42-5320-075-01 psn tib stm 5 deg sz f l lot: 63452362.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.

Event Description

It was reported that the patient was revised due to pain and clicking in the medial compartment of his left knee.The tibia component appeared to be mal-positioned.From review of the revision op notes it was noted that there was pitting on the articular surface.The tibial component was noted to be medial with osteophytes about the medial tibial plateau.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of op notes provided.Evaluation of the returned articular surface identified wear (gouges and pits) on the proximal surface.The component backside also had minimal nicks and gouges that appeared to be from removal of the device.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.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.

Event Description

No further event information available at the time of this report.

• Brand Name: PERSONA ARTICULAR SURFACE FIXED BEARING POSTERIOR STABILIZED
• Type of Device: KNEE, PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7559955
• MDR Text Key: 109743300
• Report Number: 0001822565-2018-02978
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: PK121771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 42512401011
• Device Lot Number: 62992666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 136