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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 Problems Corroded (1131); Material Erosion (1214)
Patient Problems Pain (1994); Tentorial Tears (2097)
Event Date 06/12/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-02918.
 
Event Description
It was reported the patient underwent a revision procedure approximately 7 years post implantation due to pain, elevated ion metals, and tendon tears. It was noted the neck, head, and liner were removed and replaced. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
Reported event was confirmed with operative notes provided. The revision operative note for the left hip demonstrated that the patient was revised due to pain, liner wear and elevated metal ion levels. On opening the capsule, the rim of the liner was found fractured, and somewhat mobile posterior superiorly. Upon opening the capsule, there was a minimum of intraarticular debris. The head was removed and significant corrosion about both trunnion and inside of the head. The locking ring did not function properly. The tines were spread. The fracture was isolated to the posterolateral aspect and was noted to occupy about 60 degrees of the circumference of the rim. 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. New biolox head was implanted after the black corrosion on the trunnion was cleaned. Review of the device history record identified no deviations or anomalies would contribute to reported event. 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. Multiple mdr reports were filed for this event: 0001822565-2019-03470, 0001822565-2019-03473, 0001822565 - 2019 ¿ 02918.
 
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Brand NameFEMORAL HEAD STERILE PRODUCT 12/14 TAPER
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
MDR Report Key8784610
MDR Text Key150879060
Report Number0002648920-2019-00519
Device Sequence Number1
Product Code JDL
Combination Product (y/n)N
PMA/PMN Number
K073499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 08/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/18/2022
Device Model NumberN/A
Device Catalogue Number00801803602
Device Lot Number62051730
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/12/2019 Patient Sequence Number: 1
Treatment
ZIMMER LINER CAT#00630505036 LOT #62001409; ZIMMER NECK CAT#00784802300 LOT#62010501; ZIMMER SHELL CAT#00620205222 LOT#62047996; ZIMMER STEM CAT#00771300700 LOT#61768419; ZIMMER LINER CAT#00630505036 LOT #62001409; ZIMMER NECK CAT#00784802300 LOT#62010501; ZIMMER SHELL CAT#00620205222 LOT#62047996; ZIMMER STEM CAT#00771300700 LOT#61768419
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