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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE IMPLANT

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DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE IMPLANT Back to Search Results
Catalog Number UNK ANKLE
Device Problems Loss of or Failure to Bond; Use of Device Problem; Migration
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(4).

 
Event Description

Literature article entitled: ¿literature received entitled: "a prospective study of four total ankle arthroplasty implants by non-designer investigators" written by tina lefrancois, md, frcs, et al. , published in the journal of bone &joint surgery d jbjs. Org volume 99-a d number 4 d february 15, 2017, was reviewed for mdr reportability on 09/18/2019. The main objective of the current study was to summarize the outcomes of 4 taa prostheses (hintegra, agility, mobility, and star). The main outcome measures were scores of the short form (sf)-36 mental component summary (mcs) and physical component summary (pcs) and ankle osteoarthritis scale(aos). Secondary outcomes included complications and revision rates. Out of the total of 451 total ankle arthroplasty (taa)¿s that were reviewed, 75 were agility (depuy), and 92 were mobility (depuy). The study concluded that there were acceptable outcomes for the four modern taa prosthesis. The study noted that out of 88 mobility implant patients, 82% showed a good pain relief and functional outcomes, and that 43% of the retained prosthesis had bone-implant abnormalities. Reoperations noted for the agility taa¿s were: total of 1 isolated hardware removal around the ankle. Total of 2 repeat operations outside the ankle (example: ligament repair). Total of 5 ankle gutter or heterotopic ossification debridement without metal component exchange with or without intact polyethylene exchange. Total of 2 debridement of an osteolytic cyst without exchange of metal components with or without intact polyethylene exchange. Total of 2 deep infections or wound complications requiring surgical debridement (no exchange of metal components) with or without intact. Polyethylene exchange. Total of 15 revisions due to malposition or nonunion (no infections). Total of 2 revisions of metal component(s) secondary to infection. Total of 2 amputation above the level of the ankle. Reoperations noted for the mobility taa¿s were: total of 1 isolated hardware removal around the ankle. Total of 1 repeat operations outside the ankle (example: ligament repair). Total of 3 ankle gutter or heterotopic ossification debridement without metal component exchange with or without intact polyethylene exchange. Total of 1 debridement of an osteolytic cyst without exchange of metal components with or without intact polyethylene exchange. Total of 1 deep infections or wound complications requiring surgical debridement (no exchange of metal components) with or without intact. Polyethylene exchange. Total of 14 revisions due to malposition or nonunion (no infections). Total of 3 revisions of metal component(s) secondary to infection. Total of 1 amputation above the level of the ankle. The discussion noted that depuy agility and mobility implants both demonstrated higher rates of metal component revisions and an increasing failure of the mobility prosthesis with longer-term follow-up, the most common failure mechanisms was aseptic osteolysis and talar component subsidence and early micromotion was noted. The patient¿s with agility implants were found to have higher aos scores and lower expectation scores preoperatively. The agility prosthesis demonstrated aseptic loosening and implant subsidence. It should be noted that both the agility taa and mobility taa are no longer commercially sold.

 
Manufacturer Narrative

Product complaint # (b)(4). Investigation summary ==> no device associated with this report was received for examination. Depuy synthes considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation may 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.

 
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Brand NameUNKNOWN ANKLE IMPLANT
Type of DeviceANKLE IMPLANT
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 19380-0988
6107428552
MDR Report Key9163705
Report Number1818910-2019-107946
Device Sequence Number1
Product CodeHSN
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/07/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK ANKLE
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2019
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? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/07/2019 Patient Sequence Number: 1
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