MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNIV 2-HOLE SHL 54MM LNR SZ 24; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Failure of Implant (1924); Pain (1994); Dizziness (2194); Ambulation Difficulties (2544); Balance Problems (4401); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: ref (b)(4), lot 403680 arcom liner; ref (b)(4), lot 596070 mallory stem size 9; ref (b)(4), lot 343920 modular head 32mm-3; ref (b)(4), lot 175850 screw 6.5x35mm.Foreign country: (b)(6).The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-03488, 0001825034-2021-03489, 0001825034-2021-03490, and 0001825034-2021-03491.

Event Description

It was reported the patient underwent an initial right total hip arthroplasty.The patient alleges that he experienced pain, loss of balance, dizziness and difficulty in walking and upset stomach due to the deterioration and failure of implant.Patient also alleges elevated ion levels.No revision has been reported at this time.No additional information.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was confirmed due to the review of medical records.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues legal summons line 15-16 patient alleges pain, loss of balance, elevated serum cobalt and chromium levels.Device history record (dhr) was reviewed and no discrepancies were found.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.

• Brand Name: UNIV 2-HOLE SHL 54MM LNR SZ 24
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13098300
• MDR Text Key: 285189768
• Report Number: 0001825034-2021-03487
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Public: (01)00880304229891917)260125(10)705240
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K030055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-103654
• Device Lot Number: 705240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Other
• Patient Sex: Male