MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RECAP CEMENT FMRL HD RESUR 40M; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Tissue Damage (2104); Osteolysis (2377); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant products: biomet m2a-magnum pf cup 46odx40id cat#us157846 lot#2382104.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 - 2020 - 04461.

Event Description

It was reported patient underwent a left total hip arthroplasty approximately 13 years ago.Subsequently, patient alleges to suffer from pain, shredded metal in soft tissue and metallosis.Revision is pending; no dates for revision have been reported.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It was reported patient underwent a left total hip arthroplasty approximately 13 years ago.Subsequently, patient alleges to suffer from pain, shredded metal in soft tissue and metallosis.Radiology reports note osteolysis of the periacetabular area and tendinosis with partial tearing in the gluteus minimus.Revision is pending; no date for revision have been reported.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.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: xray - 'well fixed left hip resurfacing arthroplasty in place.There is evidence of osteolysis in the periacetabular area.There is no evidence of periprosthetic fracture.'.Mri - gluteus minimus tendinosis and partial tearing otherwise normal exam cobalt 1.3 (normal 3.9), cobalt 1.3 (normal 3.9), chromium 1.3 (normal).Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause could not be determined however, off label use was identified and could have contributed to the reported event.Zimmer biomet has not confirmed the compatibility for this combination of devices within the united states.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: RECAP CEMENT FMRL HD RESUR 40M
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11111349
• MDR Text Key: 225042568
• Report Number: 0001825034-2020-04462
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: K021799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: N/A
• Device Catalogue Number: US157240
• Device Lot Number: 275420
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Other
• Patient Weight: 64