MAUDE Adverse Event Report: BIOMET UK LTD. RECAP CEMENT FMRL HD RESUR46MM

Model Number 157246

Device Problem Material Erosion (1214)

Patient Problems Pain (1994); Reaction (2414)

Event Date 05/07/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Medical product - m2a-magnum recap cup 52odx46id , item 157852 , lot 1189743 , therapy date- (b)(6) 2013.Report source, foreign - the event occurred in (b)(6).Report source, literature: borgwardt, a.Et al (2017).A randomized seven-year study on performance of the stemmed metal m2a-magnum and ceramic c2a-taper, and the resurfacing recap hip implants.The journal of arthroplasty, 1-9.Doi: 10.1016/j.Arth.2017.11.061.Reported event was unable to be confirmed due to limited information received from customer.Device history record (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.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2018-01102.

Event Description

It was reported that one patient underwent hip revision due to pain and elevated serum metal concentrations.

Event Description

Hip revision due to pain and elevated metal ion levels.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and corrected information.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: RECAP CEMENT FMRL HD RESUR46MM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7959680
• MDR Text Key: 123488351
• Report Number: 3002806535-2018-01101
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 05/03/2019

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: 01/31/2006
• Device Model Number: 157246
• Device Lot Number: 1120367
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/12/2018
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 05/03/2019
• 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: 79 YR