MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN RECAP FEMORAL HEAD; PROSTHESIS, HIP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 11/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr's were submitted for this event.Please see associated reports: 0001825034 - 2018 - 02763.Report source: foreign.The event(s) occurred in (b)(6).Report source: literature.Borgwardt, arne, et al.¿a randomized seven-year study on performance of the stemmed metal m2a-magnum and ceramic c2a-taper, and the resurfacing recap hip implants.¿ the journal of arthroplasty, 2017, doi:10.1016/j.Arth.2017.11.061.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported patients experienced elevated metal ion levels.Seven year post- total hip arthroplasty, the average chromium level was 4.74 ug/l (range 3.67-9.23).

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed as part number / lot number of device involved in the incident is unknown.Device history record (dhr) review was unable to be performed as the item and 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.

• Brand Name: UNKNOWN RECAP FEMORAL HEAD
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7431830
• MDR Text Key: 105512169
• Report Number: 0001825034-2018-02762
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

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: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/15/2018
• Supplement Dates Manufacturer Received: 06/06/2018
• Supplement Dates FDA Received: 06/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN ACETABULAR CUP
• Patient Outcome(s): Other