MAUDE Adverse Event Report: BIOMET UK LTD. RECAP CEMENT FMRL HD RESUR44MM

Catalog Number 157244

Device Problem Insufficient Information (3190)

Patient Problem Hip Fracture (2349)

Event Date 05/31/2007

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr report were filed for this event, please see associated reports: 3002806535-2018-0951.(b)(4).Concomitant medical product - m2a-magnum recap cup 50odx44id, item 157850, lot 1193386, therapy date - (b)(6) 2007.(b)(6).Report source: literature.Arne borgwardt, , lotte borgwardt, , bo zerahn, henrik daugaard, , lise borgwardt, , søren ribel-madsen, ¿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, 2017, 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.

Event Description

Information received based on a journal article entitled "a randomized seven-year study on performance of the stemmed metal m2a-magnum and ceramic c2a-taper, and the resurfacing recap hip implants" by arne borgwardt, et al.(2017).Abstract.Background: the large-diameter metal-on-metal hip prostheses were expected to have low wear and reduced dislocation rate compared to the traditional metal-on-polyethylene implants.We compare 2 such prostheses, the recap resurfacing implant and the m2a-magnum stemmed implant, with the c2a ceramic-on-ceramic stemmed implant as to clinical performance, serum concentrations of prosthesis metals, and the durability of the implants in a randomized, controlled clinical trial at 7 years of follow-up.Methods: all included patients had osteoarthritis.Preoperatively, the size of the implants was estimated from a magnetic resonance imaging (mri) scan.Follow-up data included serum cobalt and chromium concentrations, oxford and harris hip scores, leg press and abduction force, 6-minute walk distance, womac and sf-36 self-assessment scores, and from the 7th postoperative year also ultrasonography.(us) examination of the soft tissue adjacent to the implant as well as mri with metal artifact reduction sequence (mars-mri) when indicated.Results: one hundred fifty-two hips in 146 patients were included.The serum cobalt and chromium concentrations were significantly higher for the 2 metal-on-metal prostheses than for the ceramic-on ceramic, with the m2a-magnum as the highest.No significant difference was found between the groups concerning physical performance measurements and scores as well as dislocations and prosthesis survival.Five revisions were done and concerned all groups, for reasons of pain, high serum cobalt and chromium concentrations, cystic fluid collection around the joint, and infection.Metal concentrations, us, and mars-mri contributed to the decision making regarding prosthesis revision.Conclusion: metal concentrations were significantly higher for the metal-on-metal prostheses than for the ceramic-on-ceramic.The clinical performance was good in all 3 prosthesis groups.Metal concentrations, us, and mars-mri findings were of use to identify hips needing revision.(b)(4) - "diagnostics of implant failures, and revisions done" page 6.It was reported one patient underwent hip revision due to fracture of collum femoris (neck of femur) and adverse local tissue reaction (altr).Altr had been diagnosed prior to fracture.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.

Event Description

It was reported that a patient underwenta a left hip revision due to fracture of collum femoris (neck of femur) and adverse local tissue reaction (altr).

• Brand Name: RECAP CEMENT FMRL HD RESUR44MM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 7767209
• MDR Text Key: 116552262
• Report Number: 3002806535-2018-00950
• 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,health professional,l
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: 157244
• Device Lot Number: 928663
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 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: 72 YR