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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM/SLEEVE

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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM/SLEEVE Back to Search Results
Catalog Number UNK HIP FEMORAL STEM
Device Problems Material Discolored; Loss of Osseointegration; Osseointegration Problem
Event Date 07/15/2014
Event Type  Injury  
Manufacturer Narrative

This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time. A follow-up medwatch will be filed as appropriate.

 
Event Description

Patient was revised to address implant dislocation. Report also noted that the cup was vertical but well fixed. Update rec'd 4/19/2016: litigation received. Litigation alleges pain, stiffness, and decreased rom. There is no new information that would change the existing investigation. This complaint was updated on: 4/25/2016 update 8/10/16- pfs and medical records received. After review of the medical records for mdr reportability, in addition to what was previously reported, the revision surgery notes reported that there was a loose acetabular cup, but the screw had excellent purchase. The revision surgery note also reported a loose femoral component. Adding unknown srom stem. The complaint was updated on:09/07/2016.

 
Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned. A search of the complaints databases identified other reports against the femoral head and/or liner. Per procedure, this device(s) is exempt from device history record review. A search of the complaints databases identified no other reports against the remaining product/lot code combinations. Based on previous investigations this complication of joint replacement is unlikely to have been the result of a device failing to meet required specifications. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Corrective action was not indicated. Depuy considers the investigation closed. Should additional information be received the investigation will be reopened.

 
Manufacturer Narrative

Udi:(b)(4).

 
Event Description

Pfs alleges discomfort and inability to walk. After review of medical records, patient was revised to address dislocation and loose femoral component. Revision notes reported of stiffness of the hip, scar tissue was very thickened, and the s-rom was anteverted nearly 80 degrees compared to his condyles. The acetabulum was totally vertically oriented and had almost no anterversion. The cup was also noted to have micro motion and notice to be grossly loose. It was also stated that the cause of the dislocation was due to the position of the cup. There was also minimal black stained tissue or metallosis. It was also mention that patient was very stiff and very obese. Added lawyer, medical history and patient harms. Updated dor.

 
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Brand NameUNKNOWN HIP FEMORAL STEM
Type of DeviceHIP FEMORAL STEM/SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , IN 19380-0988
6103142063
MDR Report Key5932045
Report Number1818910-2016-26620
Device Sequence Number1
Product CodeLZO
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 08/10/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/07/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK HIP FEMORAL STEM
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/07/2016 Patient Sequence Number: 1
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