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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BONE SCR 6.5X20 SELF-TAP PROSTHESIS, HIP

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ZIMMER MANUFACTURING B.V. BONE SCR 6.5X20 SELF-TAP PROSTHESIS, HIP Back to Search Results
Model Number N/A
Device Problem Difficult To Position (1467)
Patient Problem No Information (3190)
Event Date 04/16/2018
Event Type  Injury  
Manufacturer Narrative

Product has been received by zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Mfr for associated product, acetabular cup: 0001825034-018 -03321.

 
Event Description

It was reported that upon inserting screw into cup, the screw went all the way through the holes. Surgeon removed the devices and completed the surgery with new devices.

 
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Brand NameBONE SCR 6.5X20 SELF-TAP
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 Key7513656
MDR Text Key108228690
Report Number0002648920-2018-00408
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
PMA/PMN NumberPK934765
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,HEALTH PROFESSION
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/05/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00625006520
Device LOT Number63989403
OTHER Device ID Number(01) 00889024119602
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/20/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/04/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/15/2018 Patient Sequence Number: 1
Treatment
010000661 / 6062452 CUP
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