MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET LETSON MODULAR PROXIMAL FEMORAL COMPONENT; HIP PROSTHESIS

Model Number N/A

Device Problems Difficult to Insert (1316); Difficult To Position (1467)

Patient Problem No Information (3190)

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the products remain implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant products: item# unk, hip-unknown-heads-unk, lot# unk; item# unk, hip-unknown-liners-unk, lot# unk; item# unk, hip-unknown-cups-unk, lot# unk; item# 150486, bow collared stem, lot# 218970; item # 31-473590, femoral inserter, lot # unk.(b)(6).Multiple reports have been submitted for this event.Please see associated reports: 0001825034-2018-01824, 0001825034-2018-01825.

Event Description

It was reported that during a hip arthroplasty, the proximal femoral component and cement stem could not be firmly assembled.Screw would not insert into the stem thread.Also, interlock didn't function properly.Subsequently, surgeon fixed the interlock without screw fixation to complete the procedure.Attempts have been made, and no further information has been provided.

Manufacturer Narrative

(b)(4).This 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.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.

Event Description

No further event information available at the time of this report.

• Brand Name: BIOMET LETSON MODULAR PROXIMAL FEMORAL COMPONENT
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7343578
• MDR Text Key: 102584331
• Report Number: 0001825034-2018-01824
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• PMA/PMN Number: PK043547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 150459
• Device Lot Number: 692350
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 03/15/2018
• Supplement Dates Manufacturer Received: 12/04/2018
• Supplement Dates FDA Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 75 YR