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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 28/+3.5, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD

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ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 28/+3.5, TAPER 12/14 BIOLOX DELTA CERAMIC FEMORAL HEAD Back to Search Results
Model Number N/A
Device Problems Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Event Date 05/06/2020
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: act artic e1 hip brg 28x44mm s50 dia28; catalog no#: ep-200150 ; lot#: 805600. Concomitant medical products: therapy date: (b)(6) 2020. The manufacturer did receive pictures and per for review. The manufacturer did not receive the device for investigation. Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming. A cause for this specific event cannot be ascertained from the information provided. As soon as supplemental information becomes available an updated report will be submitted. Zimmer biomet¿s reference number of this file is (b)(4).

 
Event Description

Patient was implanted on the unknown side and underwent revision surgery due to pain, limited range of motion, grinding sound.

 
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Brand NameBIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 28/+3.5, TAPER 12/14
Type of DeviceBIOLOX DELTA CERAMIC FEMORAL HEAD
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key10117947
MDR Text Key193930199
Report Number0009613350-2020-00231
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK071535
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/20/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberN/A
Device Catalogue Number00-8775-028-03
Device LOT Number2986097
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/01/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/19/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/18/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient TREATMENT DATA
Date Received: 06/04/2020 Patient Sequence Number: 1
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