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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ML TAPER SZ12.5 STD OFFSET PROSTHESIS, HIP

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ZIMMER BIOMET, INC. ML TAPER SZ12.5 STD OFFSET PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Corroded (1131)
Patient Problems Host-Tissue Reaction (1297); Pain (1994); Reaction (2414)
Event Date 03/28/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Additional concomitant medical products: item# unknown; unknown head; lot# unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation. Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown. 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 multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2018 - 04292.
 
Event Description
It was reported patient underwent right total hip arthroplasty. Subsequently, patient underwent a revision procedure 8 years post implantation due to altr reaction secondary to tribocorrosion/pain. Attempts were made to obtain further information; however, none is available.
 
Manufacturer Narrative
Cmp-(b)(4). This follow-up report is being submitted to relay additional information. Updated 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.
 
Manufacturer Narrative
Concomitant medical products: item number: 00-8018-040-02, item name: versys femoral head, lot #: 60829331, item number: unknown, item name: unknown longevity acetabular liner, lot #: unknown, item number: unknown, item name: unknown trilogy aceteabular shell, lot #: unknown. If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported patient was revised approximately 11 years post implantation due to elevated metal ions and pain. During the procedure, a pseudotumor and altr due to taper corrosion was noted. The femoral head and acetabular liner components were removed and replaced. No additional information is available at this time.
 
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Brand NameML TAPER SZ12.5 STD OFFSET
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key7806893
MDR Text Key117921927
Report Number0001822565-2018-04293
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
PMA/PMN Number
K161830
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00-7711-012-00
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 08/22/2018 Patient Sequence Number: 1
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