MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK HIP ACETABULAR LINER CERAMIC; CERAMIC ACETABULAR LINER

Catalog Number UNK HIP ACETABULAR LINER CERAM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994)

Event Date 04/28/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This complaint is from a literature source.Literature citation: zeng y, yin s, liang s, zeng j, yang j, shen b.Clinical outcomes, metal ion levels, lymphocyte profiles, and implant survival following five different bearings of total hip arthroplasty: a mean 10-year follow-up study.J arthroplasty.2022 apr 28:s0883-5403(22)00480-6.Doi: 10.1016/j.Arth.2022.04.031.Epub ahead of print.Pmid: 35490981.Objective/methods/study data: the purpose of this study was to investigate whether there are differences when comparing thas with 5 different bearings at a long-term follow-up of more than 10 years.From january 2010 to may 2012, 101 tha patients (134 hips) were divided into metal-on-metal group (mom, 31 hips), metal-on-polyethylene group (mop, 23 hips), ceramic-on-metal group (com, 21 hips), ceramic-on-ceramic group (coc, 33 hips), and ceramic-on-polyethylene group (cop, 26 hips).The mean follow-up period was 10.3 years.Between january 2010 and may 2012, a consecutive series of 160 patients who underwent primary tha was considered for entry into the study.All thas were performed by 5 senior orthopedic surgeons in our institution using a traditional posterolateral approach.All patients received identical porous-coated pinnacle acetabular components (depuy).Patients were divided into 5 groups as per the type of bearings that were used: group a (metal-on-metal, mom): a wrought high-carbon, cobalt-chrome-molybdenum alloy femoral head articulating against the same metal material acetabular liner (ultamet); group b (metalon-polyethylene, mop): an ultamet alloy femoral head articulating against a highly crosslinked polyethylene (hxpe) acetabular liner (marathon); group c (ceramic-on-metal, com): a zirconia-toughened alumina ceramic biolox delta modular head articulating against an ultamet alloyliner; group d (ceramic-on-ceramic, coc): a biolox delta ceramic head articulating against the same material acetabular liner; and group e (ceramic-on-polyethylene, cop): a biolox delta ceramic head articulating against a marathon hxpe liner.The same type of bearings and the same size of implants were used on both sides for patients who underwent bilateral tha.All components were supplied by depuy.The article does not provide sufficent information to determine quantities of the noted adverse events accurately.Only 3 cases required revision and they are captured within the captions of the figures 3 and 4.Figure 3 is a 71 year old woman who underwent tha in 2010.The patient received a 52-mm pinnacle acetabular component with a modular 32-mm metal liner and 32 mm plus 1.5 mm metal femoral head.The patient presented for evaluation of a painful total hip in 2021 and underwent a hip revision for pseudotumor formation ) preoperative ap view of pelvic x-ray film showing the bone defect and osteolysis in both acetabular side and proximal femoral side without implants loosening.(b) ct scan showing pseudotumor formation with communication with the hip.(c) intraoperative photograph showing a pseudocyst surrounding the hip and protruding from the joint capsule.(d) photograph of gross specimens removed.(e and f) photographs of the metal liner, metal femoral head, and neck showing the wear of the metal interface and suspicious trunnion corrosion and scratching.(g) immediate x-ray of the pelvis after revision.The implants were stable without removing and an allogeneic bone graft was performed for the bone defect.Figure 4 provides photographic and radiographic images two patients (the first patient a-c and the second patient d-e) who received ceramic-on-ceramic tha complained of hip pain and presented periprosthetic pseudotumor formation.Trunnion damage with scratching and wear of the friction surfaces were found during revision without implant loosening.Femoral neck corrosion was supposed to be the cause of pseudotumor formation.One patient was treated with an exchange of cup liner and femoral head because the implants were stable and the other patient was treated with an explantation of all the implants.(a) preoperative x-ray film of the first patient showing bone loss around the affected hip.(b) coronal t2 magnetic resonance imaging showing hyperintense, complex, and heterogeneous cystic soft tissue tumor involving the right hip abductors and iliopsoas.(c) intraoperative photograph showing periarticular mass located posterior to the femoral stem in the affected hip.(d) preoperative x-ray film of the second patient showing obvious osteolysis around the affected hip and the implants were stable.(e) axial computed tomography scan image showing massive osteolysis and soft tissue around the cup and the proximal stem.(f) postoperative x-ray of the pelvis showing the implants were not removed and the bone defect was repaired with allogeneic bone graft.Adverse event(s) and provided interventions (mom group ¿ ultamet head/ultamet liner): figure 3 ¿ 71 year old female requiring revision for pain, osteolysis (femoral and acetabular), hypersensitivity with intraoperative findings of metal wear on head and liner and corrosion on femoral stem¿s trunnion.Qty (unk) elevated metal ions in serum detected ¿ no treatment specified.Qty (unk) noted leg length discrepancy (table 3 ¿ relatable to femoral head & stem) ¿ no treatment specified.Adverse event(s) and provided interventions (related to pinnacle cup) qty (unk) cup position range is outside of acceptable range.Figure 4 qty 2 patients with pain, bone loss, osteolysis (acetabular and femoral) and pseudotumor with noted trunnion corrosion treated with revision.Adverse event(s) and provided interventions (coc group ¿ ceramic head/ceramic liner): qty (unk) noted leg length discrepancy (table 3).Figure 4 qty 2 patients with pain, bone loss, osteolysis (acetabular and femoral) and pseudotumor with noted trunnion corrosion treated with revision.Adverse event(s) and provided interventions (related to unk femoral stem) qty (unk) noted leg length discrepancy (table 3).Figure 4 qty 2 patients with pain, bone loss, osteolysis (acetabular and femoral) and pseudotumor with noted trunnion corrosion treated with revision.Adverse event(s) and provided interventions (mop group ¿ ultamet head/marathon liner): qty (unk) elevated metal ions in serum detected ¿ no treatment specified.Qty (unk) noted leg length discrepancy (table 3 ¿ relatable to femoral head & stem) ¿ no treatment specified.Dverse event(s) and provided interventions (com group ¿ ceramic head/ultamet liner): qty (unk) elevated metal ions in serum detected.Qty (unk) noted leg length discrepancy (table 3 ¿ relatable to femoral head & stem).Adverse event(s) and provided interventions (cop group ¿ ceramic head/marathon liner): qty (unk) noted leg length discrepancy (table 3 - relatable to femoral head & stem).No reported adverse events associated with poly liner.

Manufacturer Narrative

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.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

• Brand Name: UNK HIP ACETABULAR LINER CERAMIC
• Type of Device: CERAMIC ACETABULAR LINER
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 15128760
• MDR Text Key: 296852703
• Report Number: 1818910-2022-14396
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP ACETABULAR LINER CERAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• 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