MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN INSERT; EXTREMITIES, IMPLANT

Model Number N/A

Device Problems Material Erosion (1214); Fracture (1260); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Report source: foreign- event occurred in (b)(6).It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported patient has been indicated for revision to improve mechanical properties, component wear, fracture, and other issues.No revision has been reported to date.Attempts to obtain additional information have been made; however, no more is available at this time.

Event Description

It was reported patient has been indicated for revision to improve mechanical properties, fracture, and poly wear which led to metallosis and osteolysis.No revision has been reported to date.Attempts to obtain additional information have been made; however, no more is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patient has been indicated for revision due to component wear, metallosis and osteolysis.No revision has been reported to date.Attempts to obtain additional information have been made; however, no more is available at this time.

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 (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.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.H3 other text : remains implanted.

• Brand Name: UNKNOWN INSERT
• Type of Device: EXTREMITIES, IMPLANT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8977852
• MDR Text Key: 157034419
• Report Number: 0001822565-2019-03838
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• 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
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization