MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BEARING 28 MM I.D. 38 MM O.D. SIZE C PROSTHESIS, HIP

Model Number N/A

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant products: part: 00625006530, lot: j6871104, bone scr 6. 5x30 self-tap; part: 00625006530, lot: j6871104, bone scr 6. 5x30 self-tap; part: 00625006535, lot: 64894201, bone scr 6. 5x35 self-tap; part: 00625006525, lot: j6846725, bone scr 6. 5x25 self-tap; part: 31-323230, lot: 659390, 3. 2mmx30mm rnglc+ acet drl bit; part: 00700006420, lot: 64331687, trabecular metalâ¿¢ acetabular revision shell; part: 00712506254, lot: 3004361, acetabular revision system - cage, right long flange use with 62/64 mm shells; part: 00625006530, lot: 64945767, bone scr 6. 5x30 self-tap; part: 00625006530, lot: j6871102, bone scr 6. 5x30 self-tap; part: 00625006530, lot: j6871102, bone scr 6. 5x30 self-tap; part: 00625006515, lot: j6829153, bone scr 6. 5x15 self-tap; part: 00625006535, lot: j6719372, bone scr 6. 5x35 self-tap; part: 31-323240, lot: 233730, 3. 2mmx40mm rnglc+ acet drl bit; part: 00625006530, lot: j6964165, bone scr 6. 5x30 self-tap; part: 00625006530, lot: 64945771, bone scr 6. 5x30 self-tap; part: 163651, lot: j6858532, 22. 2mm dia cocr mod hd std nk; part: 650-1055, lot: 3030897, cer bioloxd option hd 28mm.

Event Description

It was reported patient underwent a revision procedure approximately four months and 20 days post-implantation due to a worn and fractured bearing. Attempts to obtain additional information have been made; however, no more is available at this time.

• Brand Name: BEARING 28 MM I.D. 38 MM O.D. SIZE C
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12197753
• MDR Text Key: 262491586
• Report Number: 0001822565-2021-01993
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 110031009
• Device Lot Number: 64689614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2020
• 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 Treatment Data

Date Received: 07/20/2021 Patient Sequence Number: 1