MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ACCOLADE 132 SIZE 3.5; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	6020-3535
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Injury (2348); Reaction (2414)
Date of Event	11/30/2009
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.Not returned.
Event or Problem Description
This pi is for revision of right hip.Patient called stating she had a right hip replacement on (b)(6) 2009.Patient is getting revised on (b)(6) 2018 due to elevated cobalt in her blood.
Additional Manufacturer Narrative
Reported event: an event regarding abnormal ion level and taper corrosion trunnionosis involving an accolade stem mated with a v40 cocr lfit head was reported.The event of abnormal ion level was confirmed based on the medical review but the event of taper corrosion (trunnionosis) was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: on (b)(6) 2018 the patient underwent a ¿revision right total hip acetabular liner and femoral head¿ for a pre and post-operative diagnosis of ¿right hip taper corrosion (trunnionosis)¿.[.] it further notes, ¿¿ elevated cobalt levels ¿ increased over last eight months ¿ minimal symptoms ¿ little bit of fluid in the hip joint ¿ it was clear ¿ soft tissues did not show any metallic staining ¿ little bit of black debris within the head and a little bit on the trunnion ¿ head sent to the company for analysis ¿ changed to 36/10° liner ¿ trunnion cleaned ¿ minimal blackened corrosion material on it ¿ titanium taper sleeve and head on clean and dry trunnion ¿¿.[.] on her (b)(6) 2018 office visit the note states, ¿doing well ¿ changed ceramic on poly bearing with titanium sleeve ¿ cobalt level is up from pre-op ¿ may indicate left hip ¿ a factor ¿ does not have any symptoms on the left ¿ repeat cobalt on (b)(6) 2019.¿ there is no documented follow-up subsequent to this visit noted.An x-ray printout available for review includes a series dated (b)(6) 2009, which is an ap of the right hip, portable supine, demonstrating a right uncemented total hip arthroplasty with one visible screw in the acetabulum.The hip is reduced and the components are in nominal position.There is no examination of explanted components and no surgical histopathology report suggesting altr, alval, or trunnionosis, and no confirmation that ¿little bit of black debris¿ in the head and on the trunnion at revision surgery was corrosion products rather than biologic material.No baseline values for the serum cobalt or serial lab reports are available.With minimal symptoms and ¿unremarkable¿ mars mri findings there is no confirmation that the symptoms described in this case were due to ¿taper corrosion (trunnionosis)¿ as noted in the pre and post-operative diagnoses in the revision operative report.Additional records were provided to the qualified clinician with the following review provided on 27-feb-2020: [.] an additional lab report of august 22, 2018 notes a cobalt of 4.4 (0-0.9) and it was previously noted to be 3.4 on may 20, 2018.[.].A december 5, 2018 lab report indicating a cobalt level of 5.3 (0-0.9), as well as a lab of february 1, 2019 indicating a cobalt level of 3.3 (0-0.9) and a may 9, 2019 lab indicating a cobalt level of 4.1 (0-0.9) are noted.[.] review of this additional documentation does not alter the conclusions of my earlier report regarding the right total hip arthroplasty.The additional information regarding the primary and revision left total hip arthroplasty surgery similarly lacks documentation confirming trunnionosis as related to the symptoms leading to revision surgery.No surgical pathology, examination of the explanted components or imaging studies are available to evaluate this clinical situation.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the clinician review indicated that there is no examination of explanted components and no surgical histopathology report suggesting altr, alval, or trunnionosis, and no confirmation that ¿little bit of black debris¿ in the head and on the trunnion at revision surgery was corrosion products rather than biologic material.No baseline values for the serum cobalt or serial lab reports are available.With minimal symptoms and ¿unremarkable¿ mars mri findings there is no confirmation that the symptoms described in this case were due to ¿taper corrosion (trunnionosis)¿ as noted in the pre and post-operative diagnoses in the revision operative report.The additional information regarding the primary and revision left total hip arthroplasty surgery similarly lacks documentation confirming trunnionosis as related to the symptoms leading to revision surgery.No surgical pathology, examination of the explanted components or imaging studies are available to evaluate this clinical situation.It has been confirmed that the reported device was mated with a v40 cocr lfit head.The root cause of this event is deemed to be caused by the v40 cocr lfit head.No further investigation for this event is required at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
Event or Problem Description
This pi is for revision of right hip.Patient called stating she had a right hip replacement on (b)(6) 2009.Patient is getting revised on (b)(6) 2018 due to elevated cobalt in her blood.

• Brand Name: ACCOLADE 132 SIZE 3.5
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 9752266
• Report Number: 0002249697-2020-00390
• Device Sequence Number: 3029434
• Product Code: LPH
• UDI-Device Identifier: 04546540510624
• UDI-Public: 04546540510624
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2020

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: 08/31/2014
• Device Model Number: 6020-3535
• Device Catalogue Number: 6020-3535
• Device Lot Number: 30727805
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 64