MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN TAPER; PROSTHESIS, HIP

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/26/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Multiple mdr's were submitted for this event.Please see associated reports: 3002806535 - 2018 - 00711 3002806535 - 2018 - 00713 3002806535 - 2018 - 00714 medical devices: unknown part/lot: head, bearing, cup, stem.Report source: foreign.The event(s) occurred in (b)(6).Report source: literature.Borgwardt, arne, et al.¿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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported in a journal article, seven patients expired prior to 8 year follow-up.The timeframe between deaths and initial hip arthroplasty were not reported.The cause of death and relation to device are unknown.No further information has been provided at this time.

Event Description

Death was not biomet implant related.

Manufacturer Narrative

(b)(4).The follow up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.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.

• Brand Name: UNKNOWN TAPER
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7431821
• MDR Text Key: 105502988
• Report Number: 3002806535-2018-00712
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Death