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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M HIP COMPONENT

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MICROPORT ORTHOPEDICS INC. FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M HIP COMPONENT Back to Search Results
Model Number PHA04416
Device Problems Naturally Worn (2988); Noise, Audible (3273)
Patient Problem Loss of Range of Motion (2032)
Event Date 04/12/2021
Event Type  Injury  
Manufacturer Narrative

This event will be updated once the investigation is complete. Trends will be evaluated.

 
Event Description

Allegedly, patient was in kitchen and felt a "pop" and then the joint squeaked. X-rays indicated a suspected cracked poly liner. During revision it was seem that the poly was intact but the patient was impinging and wearing the rim of the liner and cup. Please see attached photos. Cup was revised and a biolox delta option head was implanted. Possibly patient was externally rotating excessively leading to impingement and eccentric wear. Products not revised: profemur plasma z classic femoral stem w/long neck size 7 varus 8 degree / product id: phape244 / lot number: 0798768751605863.

 
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Brand NameFEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 M
Type of DeviceHIP COMPONENT
Manufacturer (Section D)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer (Section G)
MICROPORT ORTHOPEDICS INC.
5677 airline rd.
arlington TN 38002
Manufacturer Contact
5677 airline road
arlington, TN 38002
9018674771
MDR Report Key11812488
MDR Text Key250213377
Report Number3010536692-2021-00290
Device Sequence Number1
Product Code LZO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130376
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/12/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL NumberPHA04416
Device Catalogue NumberPHA04416
Device LOT Number1817756
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/20/2021
Event Location No Information
Date Manufacturer Received04/20/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/12/2021 Patient Sequence Number: 1
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