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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT 12/14 TAPER; PROSTHESIS, HIP
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ZIMMER MANUFACTURING B.V. FEMORAL HEAD STERILE PRODUCT 12/14 TAPER; PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Material Erosion (1214)
Patient Problems Pain (1994); Joint Swelling (2356)
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.Event was initially reported on 0001822565-2019-01668.Multiple mdr reports were filed for this event, please see associated reports: cup: 0001822565-2019-02079, 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.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.This product is currently being reported for a separate event under 0002648920-2019-00461.
 
Event Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to the reported event.The initial report was submitted in error and should be voided.This product is currently being reported for a separate event under 0002648920-2019-00461.
 
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Brand Name
FEMORAL HEAD STERILE PRODUCT 12/14 TAPER
Type of Device
PROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
MDR Report Key8673955
MDR Text Key147157851
Report Number0002648920-2019-00393
Device Sequence Number1
Product Code LPH
Combination Product (y/n)N
PMA/PMN Number
K953337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 06/28/2019
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 Date01/16/2020
Device Model NumberN/A
Device Catalogue Number00801803601
Device Lot Number61401780
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/05/2019
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
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