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

Model Number N/A

Device Problems Unstable (1667); Noise, Audible (3273)

Patient Problems Ossification (1428); Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis, due to location of device is unknown; however, an investigation of the reported event is in progress.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 - 2021 - 00995, 0001825034 - 2021 - 00996.

Event Description

It was reported the patient underwent initial left total hip arthroplasty approximately 14 years ago with a metal-on-metal construct.Subsequently upon follow up approximately 7 years later, the patient experienced a hip dislocation, instability, and clicking in the hip.Upon xray review, heterotopic ossification was noted.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected   no product was returned; visual and dimensional evaluations could not be performed.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: (summarized by hcp) findings: patient doing extremely well, satisfactory gait, no swelling, well-healed, right leg ½ inch shorter, no ambulatory aids, follow up in 6 months xray: 'left hip shows satisfactory integration of the acetabular component without abnormal lucency, no unusual lucency at the distal aspect of the modular stem, proximal stem body as usual has some lucency between it and the surrounding bone at the lateral greater trochanter, all cables are intact without unusual resorption around them' no problems with significant pain but does have a slight limp, no ambulatory aids, no instability, previous labs all negative for signs of infection recently had a misstep-related fall and landed on her right hip without irritation to the left hip follow up in 6 months 'the patient had 1 postoperative dislocation after her revision and treatment for infection and has had no further episodes but still will from time to time have a clicking or grinding that precedes the episodes of instability.' xray: 'good position and alignment.There is no abnormal lucencies and there is some heterotopic ossification seen anterior on the lateral view.The acetabulum does not have much anteversion on the standing views' follow up in 1 year   part and lot identification are necessary for review of device history records, neither were provided.  a definitive root cause cannot 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: UNKNOWN ZMR STEM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11648098
• MDR Text Key: 261203208
• Report Number: 0001825034-2021-00994
• Device Sequence Number: 1
• Product Code: KWA
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• 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: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNKNOWN CUP
• Patient Outcome(s): Other
• Patient Weight: 80