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

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Corroded (1131); Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Hypersensitivity/Allergic reaction (1907); Pain (1994); Loss of Range of Motion (2032); Test Result (2695); No Code Available (3191)

Event Date 01/01/2017

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.

Event Description

Literature article entitled, ¿pseudotumor complicated by implant loosening one year after revision ceramic on metal total hip arthroplasty: a case report¿ by devendra lakhotia and prashant kumar, published by the journal of orthopaedic case reports (2017), vol.7, no.1, pp.82-86 was reviewed for mdr reportability.This is a case report of pseudotumor formation one year after revision surgery.A (b)(6) female, with idiopathic bilateral avascular necrosis, underwent primary left hip tha in 2003 at of unknown components 3 years before evaluation presented with worsening right hip pain.Radiographs demonstrated secondary osteoarthritis right hip for which cementless ceramic on polyethylene (cop) tha was done.On the left side, there was well functioning tha without evidence of any loosening.Review of operative record identified components as cementless metal-on-polyethylene (mop) tha on left side.The posterolateral incision at left hip was well healed with no evidence of any infection.In 2011, the patient started gradual onset of pain in the left hip.Radiographs and computed tomography (ct) scan demonstrated polyethylene wearing with aseptic loosening of both acetabular and femoral components.The patient underwent revision cementless com tha left side in 2011 using 54 mm pinnacle acetabular shell, cobalt chromium metal liner, 36 mm biolox delta ceramic head, s-rom titanium alloy femoral stem with titanium sintered proximal sleeve (depuy).Intraoperative findings were loosening of femoral stem and acetabular cup along with mild metallosis on acetabulum and femoral side.Postoperative period was eventless with substantial improvement in function.After 1 year of follow-up in 2012, patient complaint of mild discomfort in the groin in the left inguinal region.On examination soft swelling, non-tender, 2 cm × 3 cm size with no signs of inflammation was present in inguinal region.Radiographs showed normal alignment and position of hip prosthesis with no signs of loosening.Ultrasonography suggestive of cystic lesion in illiopsoas area in the left anterior hip (3.76 cm × 3.12 cm × 2.95 cm) suspected to be iliopsoas bursitis.Serum inflammatory markers and complete blood counts were within normal limits.Clinical examination showed a painless normal range of motion at left hip.The patient was kept under observation after refusal for ultrasonography-guided aspiration.After one month, she complains left groin and thigh pain, limping followed by impaired ambulation in few days.The patient showed an increase in size of iliopsoas cystic lesion.Follow-up radiographs showed signs of acetabular cup superior and lateral migration, increased inclination angle with evidence of loosening and well-fixed femoral stem.Ct scan showed well circumscribed cystic lesion around the left hip with an expansion of in iliopsoas region.Ct scan also showed the superior segmental defect in the acetabulum along with loosening of acetabular cup.Positive radioisotope bone scan indicates acetabular loosening.Serum c-reactive protein was 0.6 mg/dl, and erythrocyte sedimentation rate was 28 mm/h.Her complete blood count was normal.Serum cobalt and chromium was significantly raised (serum co = 2.4 g/l, serum cr = 22.5 ¿g/l).The patient underwent revision surgery using posterolateral approach.The pseudotumor and surrounding inflamed synovitis sac was excised.The cystic soft tissue extended to hip joint was stained with features suggestive of metallosis.The loosened acetabular cup along with cobalt-chromium liner was removed.There is corrosive wear at the metal liner with large ¿black stripe¿ across the top of retrieved ceramic femoral head.The proximal femoral sleeve and the femoral taper showed no corrosion or wear.The femoral stem with proximal sleeve was well fixed with no evidence of corrosion.The intraoperative frozen section of mass showed less than 5 polymorphonuclear leukocytes per high-power field in all the three specimens.Intraoperative dark gray colored fluid analysis was done with 58% polymorphonuclear, 39% lymphocytic, and 3% mononuclear cells.After aggressive debridement of metallic and necrotic tissue, acetabular cavitary defects were filled with mixed autogenous bone graft and allograft bone chips.Operative cultures for soft tissue and fluid were both negative for infection.Histopathology was consistent with metallosis.The histopathology analysis supports morphology consistent with the metallosis as an inflammatory response to metal particles.It revealed abundant lymphocytes, histiocytes, occasional plasma cells, foreign body type giant cells, and black metal particles.At 6 months repeat serum metal ion analysis showed decrease level with cobalt and chromium levels of 1.3, 2.54 g/l, respectively.The recent cobalt and chromium measurements were 0.66 and 0.42 g/l, respectively.The patient experienced no further complications at follow up.The index revision surgery explants were of unknown origin.This report only includes the depuy revision components.

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.A worldwide lot specific complaint database search, or device history record (dhr) review was not possible because the required lot code(s) was not provided.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Corrective action was not indicated.Device history lot: null.Device history batch: null.Device history review: null.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 ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9106969
• MDR Text Key: 163297819
• Report Number: 1818910-2019-105347
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention