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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNK STEM PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Unstable (1667)
Patient Problems Ossification (1428); Failure of Implant (1924); Joint Dislocation (2374); Joint Laxity (4526); Metal Related Pathology (4530)
Event Date 09/12/2016
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. Part: 00801803602, lot: 61092931, femoral head 12/14 taper, part: unk, lot: unk, kinectiv modular neck, part: 00620205422, lot: 61301468, shell porous with cluster holes 54 mm, part: 00630505036, lot: 61294231, liner standard 3. 5 mm offset 36 mm i. D. , part: 00625006525, lot: 61307750, bone scr 6. 5x25 self-tap. Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00336, 0001822565-2021-02953, 0001822565-2021-02955, 0002648920-2021-00344, 0002648920-2021-00337.
 
Event Description
It was reported that the patient was revised 7 years post-implantation due to instability, and dislocation. Surgeon noted corrosion, joint laxity, poly liner fracture, cup migration and heterotopic ossification at the cup. The surgeon was unable to disengage head, and eto was performed and stem removed. All components explanted. Attempts have been made and no further information has been provided.
 
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Brand NameUNK 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 Key12617684
MDR Text Key276098292
Report Number0001822565-2021-02939
Device Sequence Number1
Product Code KWY
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 Consumer,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2021
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 Received01/05/2022
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 NumberN/A

Patient Treatment Data
Date Received: 10/12/2021 Patient Sequence Number: 1
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