MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN LINER; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Joint Dislocation (2374); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: item #: unknown unknown head lot #: unknown.Item #: unknown unknown stem lot #: unknown.Item #: unknown unknown cup lot #: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The product location is unknown.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: 0001825034 - 2020 - 01630.

Event Description

It was reported by the 411 group that a patient underwent a hip arthroplasty on an unknown date.The patient is being considered for a revision on an unknown day for an unknown reason.The sales rep was inquiring about implant identification.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Concomitant medical products an additional mdr report was filed for this event, please see associated report: 0001825034 - 2020 - 01871 reported event was confirmed by review of radiographs.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.X-ray review identified superior dislocation of the right femoral head.Undersized acetabular component.Heterotopic ossification.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 a patient underwent a hip arthroplasty on an unknown date.The patient is being considered for a revision on an unknown day for dislocation and heterotopic ossification.No additional information is available.

• Brand Name: UNKNOWN LINER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9952448
• MDR Text Key: 187516981
• Report Number: 0001825034-2020-01631
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

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: 03/27/2020
• Initial Date FDA Received: 04/13/2020
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other