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

Model Number	6260-9-044
Medical Device Problem Codes	Degraded (1153); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Osteolysis (2377); Ambulation or Postural Difficulties (2544); Inadequate Osseointegration (2646)
Date of Event	12/28/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Lot specific voluntary recall was initiated for the lfit v40 cocr heads within scope of a 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 analysis identified a process related anomaly as to the affected sizes and lots.The affected product has all been implanted and/or expired.Not returned.
Event or Problem Description
Patient called stating he had a right hip replacement done on (b)(6) 2008 and is experiencing pain as he walks.Patient also reported that his doctor mentioned bone loss and loosening in his hip.Patient would like to know if his implants were part of a recall.
Event or Problem Description
Patient called stating he had a right hip replacement done on (b)(6) 2008 and is experiencing pain as he walks.Patient also reported that his doctor mentioned bone loss and loosening in his hip.Patient would like to know if his implants were part of a recall.Update per the medical records received: the patient was revised on (b)(6) 2023 due to metallosis/trunnionosis at the stem-head junction and loosening of the acetabular component.The entire construct was revised to competitor implants.
Additional Manufacturer Narrative
An event regarding wear/metallosis involving a metal head was reported.The event was confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned devices was performed as part of the material analysis: "images show the accolade stem, the lfit head, and the trident insert assembled in the trident acetabular shell.On visual examination, bone growth was observed on the coated region of the stem.Image shows yellow discolouration on the trident insert consistent with oxidation, possibly a result of synovial fluid absorption.Mechanical damage was also observed on the insert.Stereo microscope image shows the presence of discolouration and material wear on the stem trunnion.Figure 4 shows explantation damage which was observed on all sides of the stem.Image shows dark discolouration observed within the head taper with black discolouration and material wear on the side walls of the head taper.A stereo microscope image of marks observed on the proximal surface of the head." material analysis: a material analysis was performed on the returned devices which concluded the following: "review of accolade tmzf hip stem, catalogue # 6020-0435, lot code 26167401, lfit cocr head, catalogue # 6260-9-044, lot code n64mme and trident insert, catalogue # 623-00-44h, lot code ky8mhe was completed for evidence of wear.Characterisation using stereo microscopy confirmed material wear of the stem trunnion and within the head taper of the lfit head.Energy dispersive spectroscopy confirmed oxidation of the stem and head in the discoloured regions, indicating corrosion.No manufacturing related defects were observed on the examined areas of the components." clinician review: a review of the provided medical records by a clinical consultant indicated: "on (b)(6) 2023 the tha in question was revised for pain, elevated serum metal ions and suspicion of component loosening.Intra-operatively metalosis was described with black staining of the tissues.The acetabulum was not well fixed and easily removed.Upon removal of the metal head black material was seen on the trunnion but the trunnion itself was "intact" heterotopic ossification was also noted.It is confirmed that the patient underwent a revision tha for pain, acetabular lack of fixation, metallosis and elevated serum metal ions.The root cause of the lack of acetabular fixation and trunnionosis cannot be determined from the documentation provided." product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to pain, loosening of the acetabular component, and trunnionosis/metallosis at the stem-head junction.The subject device has been identified to be within scope of an nc and capa.Lot specific voluntary recall 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.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 9693273
• Report Number: 0002249697-2020-00260
• Device Sequence Number: 1810575
• Product Code: JDI
• UDI-Device Identifier: 07613327032710
• UDI-Public: 07613327032710
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: 09/30/2013
• Device Model Number: 6260-9-044
• Device Catalogue Number: 6260-9-044
• Device Lot Number: N64MME
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2020
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2008
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2249697-05-07-2018-003R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male