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

Catalog Number UNK HIP FEMORAL STEM

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2010

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: no device associated with this report was received for examination.This complaint was opened to document complaints derived through a journal article review.Follow-ups were done to try and obtain additional information from the author of the journal article.No further information was received.

Event Description

"literature article abstract entitled, ¿incidence of deep infection in aseptic revision tha using vancomycin-impregnated impacted bone allograft¿ by martin a.Buttaro, et al; published by hip international (2010), vol.20, no.04, pp.535-541, was reviewed.The purpose of this study was to evaluate the recurrence of periprosthetic infection after revision surgery preformed with antibiotic impregnated bone allograft in 80 revisions performed between jan 2002 and october 2005.30 cases were implanted with a competitor construct.30 cases were implanted with a depuy ogee polyethylene cup, c stem, cmwi cement, and an unknown depuy head.The authors do not provide results specific to manufacturer therefore, all results will be included.The exact number of depuy products involved in the following events is unknown.Results: case #44: patient experienced a hematogenous infection secondary to a dental abscess which was treated with an i&d.The procedure was unsuccessful.The patient was subsequently revised with a two-stage revision to treat mrsa infection and loosening of the cup and stem.(cement, cup, head, stem).3 cases of periprosthetic fracture treated with surgical fixation.It is unknown if the fractures occurred in the acetabulum or the femur.2 revision to treat recurrent dislocations.2 cases of revision to treat a pelvic ring fracture with reconstruction.Radiographic study results: several cases of progressive osteolysis identified in serial radiographic studies- no treatment provided.Unknown number of migrated femoral stems identified on serial radiographic studies- no treatment provided.Unknown number of acetabular subsidence identified on serial radiographic studies-no treatment provided.Captured in this complaint: case 44 revised for infection and loosening of the cup and stem cup and stem: periprosthetic fracture head and liner: joint dislocation polyethylene cup: osteolysis, implant migration femoral stem: implant migration".

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS 1818910; 700 orthopaedic dr; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10946593
• MDR Text Key: 245130862
• Report Number: 1818910-2020-26167
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2020
• 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