MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH V40 COCR LFIT HEAD 44MM/+4; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	6260-9-244
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Injury (2348); Reaction (2414)
Date of Event	04/13/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event regarding wear involving an metal head was reported.The event was not confirmed.Method and results: product evaluation and results: not performed as no products were returned for examination.Clinician review: a review of the provided medical records and/or x-rays by a clinical consultant indicated: " on (b)(6) 2008 he underwent a primary left total hip arthroplasty with a diagnosis of left hip osteoarthritis.On (b)(6) 2013 plasma chromium was noted to be 1.1, which was normal (normal being 0.1 to 2.1), and cobalt was elevated at 3.4 (normal being 0 to 0.9).Subsequent values on (b)(6) 2013 were 1.4 chromium and 4.5 for cobalt, on (b)(6) 2014 chromium was 2.0 and cobalt was 5.8 and on (b)(6) 2014 chromium was 2.7 and cobalt was 5.7 and the urine cobalt and chromium levels were noted to be elevated.On (b)(6) 2014 the plan was revision of the left total hip arthroplasty and on (b)(6) 2015 a history and physical states, " pain in the hip and has elevated cobalt and chromium from a recalled stryker hip implant".On (b)(6) 2015 a revision of the left total hip arthroplasty, femur, and acetabular screws and liner, and abductor tendon repair was performed for a diagnosis of "failed left tha with metallosis and abductor tendon disruption".The operative report describes general anesthesia and notes, "pain in the setting of a recalled component".The findings at surgery were , "no significant osteolysis.Avulsion of abductor off greater trochanter.Visible metallosis.Morse taper/trunnion junction with metal debris within head and around the base of the trunnion".An office visit of (b)(6) 2015 notes, "no pain.Doing well".X-ray printouts available for review include an undated ap of the pelvis and lateral of the left hip demonstrating uncemented bilateral total hip arthroplasties, the left having a larger prosthetic head and two screws in the acetabulum.The hips are reduced and in nominal position.Multiple views of the left hip, all undated, include one ap portable, post-operative, and are unchanged from the previous description, and there are multiple undated x-rays of the left hip demonstrating the monoblock revision, long-stem uncemented, with a small head.The hip is reduced and the same acetabulum is present with the screws having been removed.Mitek anchors are noted in the greater trochanter." product history review: review of the product history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.A review of the medical review indicated " there is no examination of the explanted components.No mri images are available for review and the report only states "suggestive of altr".The modest elevation of cobalt and chromium ions in a patient with long-standing bilateral total hips in not diagnostic of pathology.Surgical histopathology is not diagnostic of altr, metallosis or pseudotumor.Based upon the information available for review, no determination can be made regarding the cause of this clinical situation described regarding the left total hip arthroplasty in this case." the subject device has been identified to be within scope of an nc and capa.Lot specific voluntary recall (b)(4) was initiated for the lfit v40 cocr heads within scope of the nc and capa.The investigation revealed that only specific catalog numbers and specific lots are impacted by the regulatory action and that the affected lots were manufactured on or before march 4, 2011.The root cause analyses identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.No further investigation is required.If the devices and additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
It was reported that the patient had a revision of the failed left hip.Stem, liner, head revised and cup was retained.Update as per medical review stated ".On (b)(6) 2015 a history and physical states, " pain in the hip and has elevated cobalt and chromium from a recalled stryker hip implant".On (b)(6) 2015 a revision of the left total hip arthroplasty, femur, and acetabular screws and liner, and abductor tendon repair was performed for a diagnosis of "failed left tha with metallosis and abductor tendon disruption".The operative report describes general anesthesia and notes, "pain in the setting of a recalled component".The findings at surgery were , "no significant osteolysis.Avulsion of abductor off greater trochanter.Visible metallosis.Morse taper/trunnion junction with metal debris within head and around the base of the trunnion".".

• Brand Name: V40 COCR LFIT HEAD 44MM/+4
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7769741
• Report Number: 0002249697-2018-02494
• Device Sequence Number: 181864
• Product Code: JDI
• UDI-Device Identifier: 07613327032758
• UDI-Public: 07613327032758
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 08/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2013
• Device Catalogue Number: 6260-9-244
• Device Lot Number: 14YMDE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-08/29/2016-007R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 84