MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RECAP CMT FMRL HD RESUR 50M; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Local Reaction (2035); Tissue Damage (2104)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 102120, repicci fmrl 54mm rm/ll792370; 102150, repicci tibial 37x6.5mm, 54860; us157856, m2a-magnum pf cup 56odx50id, 893550.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-08717.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient's right hip was revised approximately 13 years post implantation due to pain and elevated metal ions.There was evidence that part of the anterior repair of the abductors from a prior surgery had avulsed.This appeared chronic.There was some brownish staining of the tissues in the area and mild brownish discoloration of the anterior capsular area.No additional information was made available.

Event Description

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

Manufacturer Narrative

Reported event was confirmed by review of medical records.Dhr was reviewed and no discrepancies were found.Root cause was unable to 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

It was reported that the patient's right hip was revised approximately 13 years post implantation due to pain and elevated metal ions.There was evidence that part of the anterior repair of the abductors from a prior surgery had avulsed.This appeared chronic.There was some brownish staining of the tissues in the area and mild brownish discoloration of the anterior capsular area.All zimmer biomet products were removed and replaced with stryker products.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and corrected information.Concomitant medical products: us157856, m2a-magnum pf cup 56odx50id, 893550.Repicci fmrl 54mm rm/ll102120, 792370.102150, repicci tibial 37x6.5mm, 054860.902929, harpoon size 2 suture, 775000.

• Brand Name: RECAP CMT FMRL HD RESUR 50M
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7884708
• MDR Text Key: 120525993
• Report Number: 0001825034-2018-08716
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: PK021799
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2019

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 Expiration Date: 09/30/2015
• Device Model Number: N/A
• Device Catalogue Number: US157250
• Device Lot Number: 789720
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/18/2018
• Supplement Dates Manufacturer Received: 03/06/2019; 04/04/2019
• Supplement Dates FDA Received: 03/15/2019; 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR