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

Catalog Number UNK HIP ACETABULAR LINER

Device Problem Naturally Worn (2988)

Patient Problems Foreign Body Reaction (1868); Bone Fracture(s) (1870); Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930); Pain (1994); Tissue Damage (2104); Hypoesthesia (2352); Joint Dislocation (2374); Osteolysis (2377); Test Result (2695); No Code Available (3191)

Event Date 12/30/2013

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

Literature article received entitled "adverse reaction to metal debris is more common in patients following mom total hip replacement with a 36 mm femoral head than previously thought".Literature article entitled, ¿adverse reaction to metal debris is more common in patients following mom total hip replacement with a 36 mm femoral head than previously thought: results from a modern mom follow-up programme¿ by o.Lainiala, et al, published by the bone and joint journal (december 2014), vol.96-b, pp.1610-1617 was reviewed for mdr reportability.The authors conducted a retrospective study to assess the prevalence of adverse reactions to metal debris (armd) in patients with metal-on-metal (mom) total hip replacements with 36 mm heads using a pinnacle acetabular shell.The aims of this study were to investigate the prevalence of armd and of elevated blood metal ion levels, and the effect of a modern mom follow-up program on the rate of revision of patients with 36 mm head-sized pinnacle mom thrs.Between december 2002 and september 2010, a total of 371 patients (430 hips) underwent thr using a modular uncemented pinnacle acetabular component with a mom liner at our institution.This component is hemispherical, allowing an ultamet (depuy) cocr alloy liner to be used with a 36 mm diameter modular metal head (articul/eze).The head component was attached to summit, corail, s-rom or prodigy stem (depuy).1).In all, 34 patients (12.0%) experienced clanking or squeaking sounds from the hip, 28 (9.9%) a sensation of subluxation, 11 (4.0%) a sensation of pressure and 72 (25.5%) numbness in the region of the hip.For serum ion concentration, 19 (9.5%) had a level of co and five (2.5%) a level of cr higher than the mhra screening threshold of 7 ppb.Radiolucencies in the distal femur were seen in 11 hips (3.0%), in three of them in one zone only.One hip (0.3%) showed osteolysis in all five distal gruen zones: this patient underwent a revision, and both the loose femoral component and bearing couple were exchanged.Acetabular radiolucencies were seen in 15 hips (4.1%): in all three zones in two hips and in two zones in four hips.Osteolysis was seen in 13 hips (3.6%): in all three in two hips (one already revised) and in two zones in five hips, of which two have been revised.Of hips revised because of armd (32 hips, 32 patients), 14 hips (14 patients, 44%) had an angle of inclination and version of the acetabular component which was inside lewinnek¿s safe zone.113 (30%) hips underwent imaging, which showed a fluid-filled thin-walled pseudotumor in seven (6.2%), a mixed type in 13 (11.5%) and a solid pseudotumor in four hips (3.5%).The nine-year survival rate of this cohort was 96% (95% ci 95 to 98, 26 at risk), with 13 revisions having been performed.Three hips were revised for peri-prosthetic fracture, three for infection, one for loosening of the femoral component, one for loosening of the acetabular component, one for pain and subluxation, one for instability and three for armd.The three patients with armd all had pain before revision surgery.Metallosis and synovial hypertrophy were seen in all three revisions, and in one revision a fluid-filled pseudotumor in the iliopsoas region was also found.Before january 2012, two patients (three hips) died 6.1 and 7.3 years after their primary surgery, respectively, from causes unrelated to their hip replacement.At 23 months after the start of our new surveillance program, 34 further hips in 34 patients have been revised: three for infection, one for peri-prosthetic fracture, one for loosening of the femoral component and 29 for armd.Logistic regression analysis showed a trend towards female gender being a risk factor for revision for any reason.With revision owing to armd as the endpoint, the results were similar.None of the other factors studied were associated with an elevated risk of revision.The authors do not provide detailed patient information within the text.The adverse events associated with impacted products were confirmed intraoperatively and/or with blood tests.

• Brand Name: UNKNOWN HIP ACETABULAR LINERS
• Type of Device: HIP ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 9095414
• MDR Text Key: 161795121
• Report Number: 1818910-2019-105351
• Device Sequence Number: 1
• Product Code: KWZ
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2019
• 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