MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE SIZE CD; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Tissue Damage (2104)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown persona tibial component, catalog #: ni, lot #: ni, unknown persona femoral component, catalog #: ni, lot #: ni.Report source: foreign: (b)(4).The complainant has indicated that the product will not be returned to zimmer biomet for investigation, as the device was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It is reported that the patient underwent a knee arthroplasty revision approximately twenty-two (22) months post-operatively to address post-operative breakage of the articular surface and soft tissue loosening.Attempts have been made, however, no additional information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The product could not be evaluated and the reported event was not confirmed.The device history records could not be reviewed as the lot number associated with the reported event is unknown.A definitive root cause could not be determined with the information 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.

Event Description

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

• Brand Name: UNKNOWN PERSONA POSTERIOR STABILIZED ARTICULAR SURFACE SIZE CD
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11165691
• MDR Text Key: 226763706
• Report Number: 0001822565-2021-00157
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

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 Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention