MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP FEMORAL HEAD

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988)

Patient Problems Pulmonary Embolism (1498); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Thrombosis (2100); Tissue Damage (2104); Joint Dislocation (2374); No Code Available (3191)

Event Date 04/14/2020

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

The literature article entitled, "complications and re-revisions after revisions of 528 metal-on-metal hips because of adverse reaction to metal debris" written by olli lainiala, aleksi reito, jyrki nieminen and antti eskelinent published by acta orthopaedica published online on 14 april 2020 was reviewed.The article's purpose is to report reasons for re-revision and complications after revisions of mom (metal on metal) hip due to armd (adverse reaction to metal debris).Data was compiled from 528 mom hips in 466 patients (420 were stemmed and 108 were resurfacings) that were revised for armd.All resurfacing revisions received femoral stems and revision thas retained femoral stems if found well fixed and correctly positioned.Table 2 within supplementary data provides identity of implants utilized in primary included in the data set, and table 3 within supplementary data provides identity of implants utilized in revision in the data set.It is noted that depuy and non-depuy implants are listed within table 2 (primary implants) and table 3 (revision implants).The article reports all resurfacing revisions received a stem and cup implants listed in table 2.Cement manufacturer is not identified for any constructs that were cemented.Femoral stems were not identified but assumed by identified cup manufacturer.Implants were identified by cup manufacturers with information provided on bearing surface materials.The article does not provide any radiographic images for illustrative purposes.Depuy implants utilized in primary: asr femoral head (qty 68), asr cup (qty 68), asr xl femoral head (qty 237), asr xl sleeve (augment qty 237), asr xl cup (qty 237), pinnacle cup (qty 68), pinnacle metal liner (qty 68), metal femoral head, unknown femoral stem.Reasons for revision to primaries: armd.Pseudotumor.Elevated ion levels.Depuy implants utilized in revision: pinnacle cup (35 liners only exchanges occurred during revision), liner (poly or ceramic), femoral head (ceramic or metal), deltamotion cup, sleeve (augment).Adverse events associated with revision implants but not associated with specifically identified revision implants: recurrent dislocation (treated by re-revision and/or closed reduction).Periprosthetic femoral fracture (treated by re-revision).Acetabular fracture (treated by re-revision or non-operative treatment).Fracture of stem component (treated by re-revision).Aseptic loosening of stem (treated by re-revision).Recurrent armd (treated by re-revision).Infection (treated by re-revision).Fascial rupture (treated by re-suture without change of components).Hernia (no indication of treatment).Residual pseudotumor (no indication of treatment).Pulmonary embolism (no indication of treatment).Deep vein thrombosis (no indication of treatment).Bowel occlusion (no indication of treatment).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received.Root cause undetermined.Depuy synthese considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.

• Brand Name: UNKNOWN HIP FEMORAL HEAD
• Type of Device: HIP FEMORAL HEAD
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10253461
• MDR Text Key: 203673083
• Report Number: 1818910-2020-15452
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

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 HIP FEMORAL HEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 07/14/2020
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention