MAUDE Adverse Event Report: BIOMET UK LTD. CER OPTION TYPE 1 TPR SLEVE +6; HIP PROSTHESIS

Model Number N/A

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Date 05/23/2019

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.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the surgeon claimed titanium t6 taper did not fit on stem proper.

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.

Event Description

It was reported that the surgeon claimed titanium t6 taper did not fit on stem proper.

• Brand Name: CER OPTION TYPE 1 TPR SLEVE +6
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8702847
• MDR Text Key: 148158767
• Report Number: 3002806535-2019-00510
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00880304521902
• UDI-Public: 00880304521902
• Combination Product (y/n): N
• PMA/PMN Number: K082996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• 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: 650-1068
• Device Lot Number: 2939243
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1