BIOLOX DELTA HEAD 12/14 36X0 N/A 00-8775-036-02

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for BIOLOX DELTA HEAD 12/14 36X0 N/A 00-8775-036-02 manufactured by Biomet Uk Ltd..

Event Text Entries

[187570526] (b)(4). Report source: (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Concomitant medical products: medical product: biolox delta cer lnr 36mm e, catalog #: 110003634, lot #: 6548686, medical product: g7 pps ltd acet shell 52e, catalog #: 010000663, lot #: 6629812, medical product: ml taper sz12. 5 std offset, catalog #: 00-7711-012-00, lot #: 64145181. (b)(6). The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10


[187570527] It was reported that a patient underwent an initial right total hip arthroplasty. Subsequently, the patient reported pain and the feeling of the hip locking. An x- ray identified that the ceramic parts are fractured and loose. Revision surgery is planned for (b)(6) 2020. This complaint reports the implant fractured.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3002806535-2020-00191
MDR Report Key9897272
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-03-03
Date Mfgr Received2020-03-03
Device Manufacturer Date2019-05-15
Date Added to Maude2020-03-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. CHRISTINA ARNT
Manufacturer Street56 E. BELL DR.
Manufacturer CityWARSAW IN 46582
Manufacturer CountryUS
Manufacturer Postal46582
Manufacturer Phone5745273773
Manufacturer G1BIOMET UK LTD.
Manufacturer StreetWATERTON INDUSTRIAL ESTATES
Manufacturer CityBRIDGEND CF313XA
Manufacturer CountryUK
Manufacturer Postal CodeCF31 3XA
Single Use3
Previous Use Code3
Removal Correction NumberN/A
Event Type3
Type of Report3

Device Details

Brand NameBIOLOX DELTA HEAD 12/14 36X0
Generic NameHIP ARTHROPLASTY
Product CodeLZO
Date Received2020-03-30
Model NumberN/A
Catalog Number00-8775-036-02
Lot Number2989510
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIOMET UK LTD.
Manufacturer AddressWATERTON INDUSTRIAL ESTATES BRIDGEND CF313XA UK CF31 3XA


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-30

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