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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. BEARING 28 MM I.D. 38 MM O.D. SIZE C PROSTHESIS, HIP Back to Search Results
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.
 
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Brand NameBEARING 28 MM I.D. 38 MM O.D. SIZE C
Type of DevicePROSTHESIS, 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 Key12197753
MDR Text Key262491586
Report Number0001822565-2021-01993
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190656
Number of Events Reported1
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 Received07/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number110031009
Device Lot Number64689614
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 Received09/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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