MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RECAP PF FMRL HD RESURF 44MM; PROSTHESIS, HIP

Model Number N/A

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Date 08/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: us157850, m2a-magnum pf cup 50odx44id, 764260.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-09219.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that patient's right hip was revised approximately 3 years post implantation due to pain, discomfort, elevated metal ions and lack of mobility.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.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.

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 by review of revision op notes.Primary op notes were reviewed and no complications were identified.Revision op notes reviewed and it was identified patient was revised due to elevated metal ions.Blackish fluid were noted within the bursa consistent with metallosis.No muscle destruction identified but some synovitis was noted.Device history record 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 patient's right hip was revised approximately 3 years post implantation due to pain, discomfort, elevated metal ions and lack of mobility.During the surgery, blackish fluid noted within the trochanteric bursa.Metallosis was identified.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.A recap pf fmrl hd resurf 44mm was returned and evaluated against the complaint.Visual inspection found the head to be filled and post to be surrounded by foreign material.The head is scuffed and scratched.Device history record (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

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

• Brand Name: RECAP PF FMRL HD RESURF 44MM
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7938242
• MDR Text Key: 122849985
• Report Number: 0001825034-2018-09220
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• PMA/PMN Number: PK023188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/19/2021

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: 09/30/2019
• Device Model Number: N/A
• Device Catalogue Number: US157144
• Device Lot Number: 094750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 10/05/2018
• Supplement Dates Manufacturer Received: 02/18/2019; 03/07/2019; 01/15/2021
• Supplement Dates FDA Received: 02/20/2019; 04/03/2019; 01/22/2021
• 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