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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRABECULAR METAL MODULAR SHELL POROUS WITHOUT HOLES; PROSTHESIS, HIP
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ZIMMER BIOMET, INC. TRABECULAR METAL MODULAR SHELL POROUS WITHOUT HOLES; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Twisted/Bent (2981)
Patient Problem Pain (1994)
Event Date 08/26/2014
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 medical products: part: 00801803601, femoral head 12/14 taper, lot: 61401780, part: 00620205621, shell porous without holes 56 mm, lot: 61293570, part: 00630505636, liner standard 3.5 mm offset 36 mm i.D., lot: 61330270, part: 00771101200, femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 12.5 standard offset, lot: 60968914.Multiple mdr reports were filed for this event, please see associated reports: head: 0002648920-2019-00350, liner: 0002648920-2019-00351.
 
Event Description
It was reported that a patient underwent left hip arthroplasty, subsequently the patient underwent a revision procedure approximately four and a half years later due to pain.It was noted on mri that the patient had an effusion.During the revision procedure, it was noted that the liner was fractured and the locking mechanism was not functioning.The liner and head was removed and replaced.Attempts have been made and no further information has been provided.
 
Event Description
It was reported that a patient underwent left hip arthroplasty, subsequently the patient underwent a revision procedure approximately four and a half years later due to pain.It was noted on mri that the patient had an effusion.During the revision procedure, it was noted that the liner was fractured and the locking mechanism was not functioning.The liner and head was removed and replaced.Revision operative notes identified that the patient was revised due to pain, liner wear and elevated metal ion levels.The rim of the liner was found fractured and the locking mechanism was bent, preventing the locking mechanism from opening freely.Corrosion was also identified about both the trunnion and the inside of the head.The head, liner and locking ring were removed and replaced.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The product was evaluated through manufacturing review and the reported event was confirmed through review of medical records.The device history records were reviewed and no discrepancies relevant to the reported event were identified.A definitive root cause could not be determined with the information 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.
 
Event Description
No further information at the time of this report.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Visual examination of the returned product identified the tabs are damaged and sprung open.Damage is also seen on the edge / rim of the device.Damage is too severe for dimensional analysis.Review of the device history record identified no deviations or anomalies would contribute to reported event.The revision op note for the left hip demonstrated that the locking ring did not function properly.The tines were spread.The locking mechanism was bent and it did not open freely.The locking ring was removed, new locking ring and liner were implanted.The cup was somewhat retroverted and well-fixed.A definitive root cause cannot be determined.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.
 
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Brand Name
TRABECULAR METAL MODULAR SHELL POROUS WITHOUT HOLES
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8673952
MDR Text Key147157184
Report Number0001822565-2019-02079
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K093561
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2019
Device Model NumberN/A
Device Catalogue Number00620205621
Device Lot Number61293570
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age74 YR
Patient SexMale
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