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

Catalog Number UNK HIP FEMORAL HEAD

Device Problems Corroded (1131); Degraded (1153)

Patient Problems Edema (1820); Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); No Code Available (3191)

Event Date 07/30/2014

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, "pseudotumor and deep venous thrombosis due to crevice corrosion of the head¿neck junction in metal-on-polyethylene total hip arthroplasty" written by hiroshi watanabe, kenji takahashi, kenji takenouchi, akiko sato, hidemi kawaji, hiroshi nakamura, and shinro takai published by journal of orthopaedics j orthop sci doi 10.1007/s00776-014-0623-2 on 30 july 2014 was reviewed for mdr reportability.The article reported on a case study of a (b)(6) woman who underwent right tha in 1997 and left tha in 1994.Both hips received depuy duraloc shells with uncemented aml stem and cocr femoral head along with a poly liner.Joint revision surgery performed in 2006 due to bilateral hip pain with root cause of poly wear.The head and poly liner were explanted and replaced on both hips with noted presence of poly wear debris in soft tissue.Three years post revision surgery she develop left hip pain.She revealed no evidence of inflammation in her inflammatory marker assessment.Her left lower limb then demonstrated edema and a ct exam revelaed a cystic tumor in her left hip.Dvt was suspected in lower left leg.A second revision surgery took place.Excisional biposy of the tumor was performed and a gray friable mass was found along the ilipsoas and iliacus msucle and was surgically removed.Pathology reveal significant necrotizing connective tissue but tumor cells were absent.Also present with reddish brown, muddy fluid around hip joint surface as well as black metal debris on head - neck junction.Poly liner was found to have minimal wear and cup was well fixed.Femoral head was explanted and replaced and further examination revealed corrosion on the femoral head taper.It was noted she experienced foreign body reaction and hypersensitivity to metal-ion presence rather than related to particles.Edema and pain resolved 1 month post 2nd revision and no dvt was found.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device was received.Root cause undetermined.Depuy synthes 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• 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 ; 6103142063
• MDR Report Key: 9187420
• MDR Text Key: 173009370
• Report Number: 1818910-2019-109024
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2019
• 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