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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN AVENIR STEM PROSTHESIS, HIP

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ZIMMER BIOMET, INC. UNKNOWN AVENIR STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Corroded (1131)
Patient Problem Metal Related Pathology (4530)
Event Date 01/17/2022
Event Type  Injury  
Event Description
It was reported patient underwent a hip revision approximately 8 years post implantation due to metallosis and atlr. During the procedure the 32mm +10. 5 cocr head was removed and there was some corrosion noted inside the head and on the trunnion. The depuy liner was removed and replaced with an offset liner. A zimmer biolox option head, 32/+7 was implanted. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4). Femoral head sterile product do not resterilize 12/14 taper- (b)(4) unknown- depuy pinnacle cup-unknown. Unknown-unknown depuy liner-unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2022- 00360. Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device remains implanted.
 
Manufacturer Narrative
(b)(4). Concomitant medical products: femoral head sterile product do not resterilize 12/14 taper- (b)(4) unknown- depuy pinnacle cup-unknown. Unknown-unknown depuy liner-unknown. Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2022- 00360. Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Device remains implanted.
 
Event Description
It was reported patient underwent a hip revision approximately 8 years post implantation due to metallosis and atlr. During the procedure the 32mm +10. 5 cocr head was removed and there was some corrosion noted inside the head and on the trunnion. The depuy liner was removed and replaced with an offset liner. A zimmer biolox option head, 32/+7 was implanted. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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Brand NameUNKNOWN AVENIR STEM
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 Key13483919
MDR Text Key285321672
Report Number0001822565-2022-00361
Device Sequence Number1
Product Code KWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberNI

Patient Treatment Data
Date Received: 02/08/2022 Patient Sequence Number: 1
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