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

Catalog Number UNK ANKLE

Device Problems Loss of or Failure to Bond (1068); Use of Device Problem (1670); Migration (4003)

Patient Problems Ossification (1428); Cyst(s) (1800); Bone Fracture(s) (1870); Unspecified Infection (1930); Tissue Damage (2104); Osteolysis (2377); Inadequate Osseointegration (2646); No Code Available (3191)

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.

• Brand Name: UNKNOWN ANKLE IMPLANT
• Type of Device: ANKLE 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 Key: 9163705
• MDR Text Key: 169486080
• Report Number: 1818910-2019-107946
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ANKLE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 12/16/2019
• Supplement Dates FDA Received: 12/17/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention