MAUDE Adverse Event Report: BIOMET UK LTD. CER BIOLOXD OPTION HD 40MM; HIP PROSTHESIS

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a supplemental mdr will be submitted.Concomitant medical products: medical product:cer option type 1 tpr sleve +6 catalog #: 650-1068 lot #: 2953805.Mdr reports were filed for this event, please see associated reports: 3002806535-2019-00537.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported by the hospital that during a hip replacement procedure, the implant would not assemble with mating implant.Subsequently, another product was used to complete the procedure.

Event Description

It was reported by the hospital that during a hip replacement procedure, the implant would not assemble with mating implant.Subsequently, another product was used to complete the procedure.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Following visual, dimensional and assembly checks of the returned items, no discrepancies have been identified, therefore the reported event has not been confirmed.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.

• Brand Name: CER BIOLOXD OPTION HD 40MM
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8734964
• MDR Text Key: 149207666
• Report Number: 3002806535-2019-00536
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00880304521933
• UDI-Public: 00880304521933
• Combination Product (y/n): N
• PMA/PMN Number: K141653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 650-1058
• Device Lot Number: 2957980
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1