MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR CUP

Catalog Number UNK HIP ACETABULAR CUP

Device Problems Loss of Osseointegration (2408); Osseointegration Problem (3003)

Patient Problems Adhesion(s) (1695); Edema (1820); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Necrosis (1971); Pain (1994); Inadequate Osseointegration (2646); Test Result (2695); No Code Available (3191)

Event Date 01/01/2011

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 subsequent implant loosening as a complication of revision total hip arthroplasty with ceramic-on-metal bearing: a case report" written by lokesh gudda naik, md, won yong shon, md, i.C.Clarke, phd, jun-gyu moon, md, piyush mukund, md, and sang-min kim, md published by hip and pelvis accepted by publisher 5 november 2018 was reviewed.The article's purpose was to report on one case report of a (b)(6) year old female who received initial left tha in 2003.Original implants are not identified.However in 2011 she received a revision to the l hip and was implanted with depuy products of pinnacle cup, cocr metal liner, 36 mm ceramic head and srom titanium alloy stem with sleeve.Intraoperative findings at the time of revision for the unknown original implants included loose stem, loose cup, metallosis of both femoral and acetabulum regions.One year post revision patient reported mild discomfort in the left inguinal region.Examination notes non-tender swelling and no signs of inflammation, and radiographs reveal normal alignment and no loosening.Ultrasonography reveals a cystic lesion in the iliopsoas area and suspected to be bursitis.Patient refused aspiration and was kept for observation.After additional month, patient complained of pain and started to limp and note of swelling has increased.Radiographs reveal migration of the acetabular cup and well fixed stem.Ct scan reveals a well-circumscribed lesion in the iliopsoas region, lysis and positive radioisotope indicated acetabular loosening.Also noted is cr serum was 22.5 mcg/l.Revision surgery commenced which included excision of pseudotumor and inflamed surrounding synovial sac.Confirmation of metallosis with stained black tissue.The loosened cup with cocr liner was removed.Note of corrosive wear on liner and "large black stripe" on retrieved ceramic head.No adverse events associated with in situ stem.Metallic and necrotic tissue was aggressively debrided and thorough lavage.Bone grafting performed for acetabular cavitary defects.No further complications and patient's crco levels and functions improved.Figures 1-5 provides radiographic and photographic images of post first and second revision surgeries and the retrieved implants along with ultrasound and ct images to capture the lesion.Figure 6 is histological sections of tissues samples taken at the 2nd revision when the depuy implants were removed.Depuy products: pinnacle cup, metal liner, ceramic head, srom stem system.Adverse events leading to revision surgery and explantation : reports of pain and swelling accompanied by limp followed by diagnostic testing and assessments revealing lesion, inflammation, elevated blood ion levels.Confirmed intraoperative findings of loose cup, metallosis, pseudotumor, necrotic tissue (debrided and lavage), liner wear with corrosion.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.  product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP ACETABULAR CUP
• Type of Device: HIP ACETABULAR CUP
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 10012490
• MDR Text Key: 190316645
• Report Number: 1818910-2020-11525
• Device Sequence Number: 1
• Product Code: KWA
• 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: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR CUP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention