MAUDE Adverse Event Report: BIOMET UK LTD. UNKNOWN TAPERLOCK STEM; UNKNOWN HIP ARTHROPLASTY

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Metal Related Pathology (4530)

Event Date 06/29/2008

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted.Concomitant medical products: medical product: medical product: unknown magnum cup, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00076.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product remains implanted.

Event Description

It was reported that a patient underwent an initial right hip arthroplasty on (b)(6) 2008.Subsequently, an orthopedic visit on (b)(6) 2009 revealed an anomalous distribution of load, causing significant pain in the lumbar area, and a further neurological examination made on (b)(6) 2010 confirmed the diagnosis.A claim for damages is made, allegedly caused by the adverse reaction to the metal ions (chromium and cobalt) released by the magnum cup and taperloc stem.Legal will not investigate the case, because the claim is time-barred.

Event Description

The patient's legal counsel reported that the patient underwent an initial right hip arthroplasty on (b)(6) 2008.Patient underwent an initial right hip arthroplasty on (b)(6) 2008.Subsequently, an orthopedic visit on (b)(6) 2009 revealed an anomalous distribution of load, causing significant pain in the lumbar area, and a further neurological examination made on (b)(6) 2010 confirmed the diagnosis.A claim for damages is made, allegedly caused by the adverse reaction to the metal ions (chromium and cobalt) released by the magnum cup and taperloc stem.Note: legal will not investigate the case, because the claim is time-barred.Attempts have been made and no further information has been provided.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.D11: medical product: medical product: unknown magnum cup, catalog #: unknown, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 3002806535-2021-00076-1.As the product has not been received, the investigation was limited to the information provided.In addition, we have not been provided with x-rays or any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as item numbers and lot numbers are unknown.A review of the complaint database could not be performed as item numbers and lot numbers are unknown.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Risk assessment: without the opportunity to examine the complaint product and without adequate information received regarding the event, root cause could not be determined and therefore risk could not be assessed against occurrence or any new previously unidentified risk.

• Brand Name: UNKNOWN TAPERLOCK STEM
• Type of Device: UNKNOWN HIP ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11468652
• MDR Text Key: 244800398
• Report Number: 3002806535-2021-00077
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR