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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 10/25/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Udi- (b)(4).Medical product - m2a-magnum recap cup 52odx46id, item 157852 , lot 1422259.Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It has been reported that a patient underwent a recap revision into total hip ( mallory head stem and avantage cup ) due to elevated metal iron levels.

Manufacturer Narrative

(b)(4).Products have been returned to biomet uk ltd for evaluation and forwarded to a research engineer for investigation.Summary of investigation (from far489): a ø46 mm recap femoral head and recap magnum acetabular cup were revised after an unknown period (maximum 9 years and 6 months) due to ¿elevated metal ion levels¿.The exact numerical values of these levels have not been provided.Both the femoral head and acetabular shell have scratches on their articulating surfaces that may be indicative of third-body wear.Possible sources of third-body particles in the joint space include small pieces of bone debris, bone cement or osteophytes.Metal debris delaminated from the pps coating is another possible source.The presence of such particles in the joint space before revision cannot be confirmed without radiographs and surgical notes for the primary and the revision surgery.The articulating surface of the femoral head displays a wear stripe that extends over the side of the wear patch.This can arise when the acetabular component is sub-optimally positioned or if the patient has a degree of joint laxity, and can also lead to acetabular rim damage as observed in this case.Both may lead to excessive wear, which can explain the reported elevated metal ion levels.However it is not possible to confirm these factors or component positioning with the information that has been provided.At the time of writing this report, radiographs have not been provided for analysis and there are no surgical notes or details regarding implant positioning, histological analyses, patient¿s height, weight or activity levels.It was specified in the zimmer biomet product experience report (zper) that ¿hospital does not give any x-rays and no patient data to zimmer biomet for privacy reasons¿.The ultimate reason for revision cannot be determined with the available information.Review of the device history records for reported components identified no deviations or anomalies that could contribute to the reported event.A review of the complaint database over the last 3 years has found no similar complaints reported with this item / lot number combination.In order to investigate the matter thoroughly access is needed to certain patient co-morbidities, mris, ct scans, full x-rays including laterals (pre- and post- primary surgery), routine blood tests to include inflammatory markers, hip aspiration to exclude infection, intra operative findings, histological findings and confirmation of armd/alval.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated, and subsequently a supplemental report will be provided where deemed required.

• 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: 7626868
• MDR Text Key: 111977154
• Report Number: 3002806535-2018-00901
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: N/A
• Device Catalogue Number: 157246
• Device Lot Number: 1488182
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 07/27/2018
• Supplement Dates FDA Received: 08/07/2018
• 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