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

Catalog Number UNK HIP ACETABULAR LINER

Device Problems Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994); No Code Available (3191)

Event Date 09/24/2013

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 entitled, ¿early surveillance of ceramic-on-metal total hip arthroplasty¿ by j.C.Hill, et al, published by the bone and joint journal (2015), vol.97-b, pp.300-305, was reviewed for mdr reportability.This study reports a single surgeon series of com thas, with outcomes including implant survival, radiological outcomes, blood ion levels, and clinical outcomes including pain and patient-reported outcome measures (proms).A total of 287 com thas (271 patients) were performed under the care of the senior author (deb) between october 2007 and october 2009.In all cases, a corail femoral stem was used with a biolox delta ceramic head, and a pinnacle metal liner (all depuy).28 mm, 32 mm and 36 mm diameter modular heads were used; all were available with three lengths of neck (1.5 mm, 5 mm, 8.5 mm).The mean follow-up time for the surveillance review was 34 months.At this time, three patients (four hips) had died, and two (two hips) had been lost to follow-up.Three patients (three hips) were unable to attend and were reviewed by telephone; these did not have radiographs or metal ion measurements.As a result, 281 hips (266 patients) were reviewed, of which 278 hips (263 patients) had radiographs and metal ion measurements.Six patients (2%) complained of noise (clicking, grinding or juddering) from the hip.As of august 2014, eight patients (eight thas) have undergone a revision due to pain.Two further patients were offered revision as the first had a pseudotumor surrounding the greater trochanter and the second showed radiographic changes in zones 1, 7, 8 and 14, as well as experiencing pain.Neither, however, underwent the procedure.One was considered too high risk for anesthesia and the other refused surgery as his symptoms were tolerable despite the identification of a pseudotumor on mri.The median blood levels of cobalt and chromium in all 263 patients (278 thas) were 0.83¿g/l (0.24 to 27.56) and 0.78¿g/l (0.21 to 8.84), respectively.A total of 31 patients (12.5%, 35 thas) had blood cobalt levels of > 2 ¿g/l, and six patients had levels of > 7 ¿g/l (2.5%, seven thas).For chromium, 26 patients (11.1%, 31 thas) had levels of > 2 ¿g/l, and one patient (0.4%, one tha) had levels of > 7¿g/l.The authors identify 8 patients and reasons for revision on table ii.These patients are included within the spreadsheet labeled case 1- case 8.Please link to parent (b)(4).Impacted products: pinnacle cup and liner, biolox ceramic head, corail femoral stem.Revised acetabular components 55 months after index tha due to implant noise reported as "juddering" and pain.Co 5.4 ppb, cr 2.6 ppb.Fluid collection within the joint capsule confirmed intraoperatively.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.The complaint was received into the company in the form of a literature paper with the following comment: literature article entitled, ¿early surveillance of ceramic-on-metal total hip arthroplasty¿ by j.C.Hill, et al, published by the bone and joint journal (2015), vol.97-b, pp.300-305.No products were received and no further product information was received.The literature paper was forwarded to clinical specialists for review.They commented: this study reports a single surgeon series of com thas, with outcomes including implant survival, radiological outcomes, blood ion levels, and clinical outcomes including pain and patient-reported outcome measures (proms).A total of 287 com thas (271 patients) were performed under the care of the senior author (deb) between (b)(6) 2007 and (b)(6)2009.In all cases, a corail femoral stem was used with a biolox delta ceramic head, and a pinnacle metal liner (all depuy).28 mm, 32 mm and 36 mm diameter modular heads were used; all were available with three lengths of neck (1.5 mm, 5 mm, 8.5 mm).The mean follow-up time for the surveillance review was 34 months.At this time, three patients (four hips) had died, and two (two hips) had been lost to follow-up.Three patients (three hips) were unable to attend and were reviewed by telephone; these did not have radiographs or metal ion measurements.As a result, 281 hips (266 patients) were reviewed, of which 278 hips (263 patients) had radiographs and metal ion measurements.Six patients (2%) complained of noise (clicking, grinding or juddering) from the hip.As of august 2014, eight patients (eight thas) have undergone a revision due to pain.Two further patients were offered revision as the first had a pseudotumor surrounding the greater trochanter and the second showed radiographic changes in zones 1, 7, 8 and 14, as well as experiencing pain.Neither, however, underwent the procedure.One was considered too high risk for anesthesia and the other refused surgery as his symptoms were tolerable despite the identification of a pseudotumor on mri.The median blood levels of cobalt and chromium in all 263 patients (278 thas) were 0.83¿g/l (0.24 to 27.56) and 0.78¿g/l (0.21 to 8.84), respectively.A total of 31 patients (12.5%, 35 thas) had blood cobalt levels of > 2 ¿g/l, and six patients had levels of > 7 ¿g/l (2.5%, seven thas).For chromium, 26 patients (11.1%, 31 thas) had levels of > 2 ¿g/l, and one patient (0.4%, one tha) had levels of > 7¿g/l.The authors identify 8 patients and reasons for revision on table ii.These patients are included within the spreadsheet labeled case 1- case 8.Please link to parent pc-000549629.Impacted products: pinnacle cup and liner, biolox ceramic head, corail femoral stem.Revised acetabular components 55 months after index tha due to implant noise reported as "juddering" and pain.Co 5.4 ppb, cr 2.6 ppb.Fluid collection within the joint capsule confirmed intraoperatively.Without returned parts, no further investigation of the associated products can be made.No investigation as to manufacturing defects can be made without product codes and batch numbers.Post-market surveillance is per sep-419.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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.Device history lot: null.Device history batch: null.Device history review: null.

• 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: 9149317
• MDR Text Key: 167562641
• Report Number: 1818910-2019-107148
• Device Sequence Number: 1
• Product Code: LZO
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• 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: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention