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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL AUGMENT
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DEPUY ORTHOPAEDICS, INC. 1818910 UNKNOWN HIP FEMORAL AUGMENT Back to Search Results
Catalog Number UNK HIP FEMORAL AUGMENT
Device Problems Corroded (1131); Appropriate Term/Code Not Available (3191)
Patient Problems Infarction, Cerebral (1771); Foreign Body Reaction (1868); Memory Loss/Impairment (1958); Muscle Weakness (1967); Pain (1994); Tissue Damage (2104); Osteolysis (2377); Test Result (2695); Not Applicable (3189); No Code Available (3191)
Event Date 12/29/2016
Event Type  Injury  
Event Description
Update jun 22, 2017: legal medical records received.In addition to what was previously alleged , pfs alleges reduced muscle strength, memory loss and decreased daily activities.After review of the medical records for the mdr reportability, patient was revised due to pain and osteolysis secondary to adverse tissue response.Revision notes stated that posterior capsule was intact, but distended.The joint was filled with dark brown gritty paste consistent with foreign body reaction.There was lysis into the greater trochanter around the margins of the sleeve of the hip stem, but the sleeve was well fixed to bone and not loose.There was also lysis around the margins of the acetabular component and through the open screw holes and somewhat into the ischium, but the cup appeared to be well fixed and not loose.The synovium was dark brown stained approximately a millimeter and half thick.It was also reported that there was corrosion visible between the femoral head and the neck taper and also there was corrosion between the stem and the sleeve.It was also stated that, radiographically, there has been some migration of the femoral stem into varus.Laboratory results for metal ions were below 7ppb.No part/lot information received.This complaint was updated on june 29, 2017.
 
Event Description
Update jun 22, 2017: legal medical records received.In addition to what was previously alleged , pfs alleges reduced muscle strength, memory loss and decreased daily activities.After review of the medical records for the mdr reportability, patient was revised due to pain and osteolysis secondary to adverse tissue response.Revision notes stated that posterior capsule was intact, but distended.The joint was filled with dark brown gritty paste consistent with foreign body reaction.There was lysis into the greater trochanter around the margins of the sleeve of the hip stem, but the sleeve was well fixed to bone and not loose.There was also lysis around the margins of the acetabular component and through the open screw holes and somewhat into the ischium, but the cup appeared to be well fixed and not loose.The synovium was dark brown stained approximately a millimeter and half thick.It was also reported that there was corrosion visible between the femoral head and the neck taper and also there was corrosion between the stem and the sleeve.It was also stated that, radiographically, there has been some migration of the femoral stem into varus.Laboratory results for metal ions were below 7ppb.No part/lot information received.This complaint was updated on june 29, 2017.
 
Manufacturer Narrative
Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Update ad 30 may 2018: (b)(4) has been re-opened under (b)(4) due to the receipt of ppf record.In addition to what were previously alleged, ppf alleges metallosis, stroke and elevated metal ions.
 
Event Description
Ppf alleges metallosis and elevated metal ions.After review of medical records for the mdr reportability, there is no revision notes provided.It was stated that patient had pinnacle cup, single screw, metal liner, s-rom head, s-rom stem and s-rom sleeve implanted.Implant sticker sheets were not provided.Revision stickers sheets were provided and indicated that a new head, liner and stem were implanted on (b)(6) 2016.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.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.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
UNKNOWN HIP FEMORAL AUGMENT
Type of Device
HIP FEMORAL AUGMENT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key6416021
MDR Text Key70298799
Report Number1818910-2017-14899
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK HIP FEMORAL AUGMENT
Was Device Available for Evaluation? No
Date Manufacturer Received05/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age62 YR
Patient Weight84
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