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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. COCR FEMORAL HEAD PROSTHESIS, HIP

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ZIMMER MANUFACTURING B.V. COCR FEMORAL HEAD PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problems Corroded; Metal Shedding Debris; Naturally Worn
Event Date 11/14/2014
Event Type  Injury  
Manufacturer Narrative

(b)(4). Concomitant medical products: 00784301408, revision femoral stem beaded fullcoat plus 12/14 neck taper, 60954353, 00620205820, shell porous with multi holes 58 mm, 61764051, 00630505840, liner standard 3. 5 mm offset 40 mm, 61730068, 00625006520, bone scr 6. 5x20 self-tap, 61770032, 00625006520, bone scr 6. 5x20 self-tap, 61785591. 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: 0001822565-2017-06314. Product location unknown.

 
Event Description

It was reported by the patient's legal counsel that the patient's right hip was revised approximately three years post-implantation due to pain and discomfort caused by metal debris, tissue reaction, trunniosis, and elevated metal ion levels. Attempts have been made and additional information on the reported event is unavailable.

 
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Brand NameCOCR FEMORAL HEAD
Type of DevicePROSTHESIS, HIP
Manufacturer (Section D)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer (Section G)
ZIMMER MANUFACTURING B.V.
turpeaux industrial park
route #1 km 123.4 bldg #1
mercedita PR 00715
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw , IN 46582
5745273773
MDR Report Key7377940
Report Number0002648920-2018-00242
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberN/A
Device Catalogue Number00801804003
Device LOT Number61790581
OTHER Device ID NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/06/2011
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: 03/28/2018 Patient Sequence Number: 1
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