MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR DUAL MOBILITY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	626-00-46F
Medical Device Problem Codes	Material Erosion (1214); Mechanical Problem (1384)
Health Effect - Clinical Codes	Loss of Range of Motion (2032); Metal Related Pathology (4530)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6) 2014 and was revised on (b)(6) 2021.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.Update on 26-nov-2021 per clinician review: "[.] (b)(6) 2021: operative note [.] some metallosis in hip, some impingement of the posterior neck on the mdm liner [.] confirmation: a revision surgery was performed.Impingement noted at the time of revision with notching of the neck.[.]".
Event or Problem Description
It was reported through the filing of a lawsuit that allegedly the patient was implanted with an lfit anatomic cocr v40 femoral head on his left hip on or about (b)(6), 2014 and was revised on (b)(6), 2021.It is further alleged that he suffered injuries as a result of implantation and explantation of the device(s) at issue, device recall and excessive levels of chromium and cobalt in his blood.*update on (b)(6) 2021 per clinician review: (b)(6) 2021: operative note some metallosis in hip, some impingement of the posterior neck on the mdm liner confirmation: a revision surgery was performed.Impingement noted at the time of revision with notching of the neck.
Additional Manufacturer Narrative
Reported event an event regarding impingement/rom, wear/metallosis and abnormal ion level involving a mdm liner was reported.The event of impingement and metallosis was confirmed via clinician review and the event of abnormal ion level was not confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: confirmation: a revision surgery was performed.Impingement noted at the time of revision with notching of the neck.Injuries and/or excessive levels of chromium and cobalt could not be confirmed.Root cause: a root cause cannot be ascertained without additional medical records.That said, impingement and notching of the femoral neck was noted at the time of the revision and this could certainly explain the concern and/or finding of increased metal levels (if confirmed) and metallosis.Poduct 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: it was reported that the patient's hip was revised due to excessive levels of chromium and cobalt in his blood, metallosis and impingement of the posterior (stem) neck on the mdm liner.Clinician review of provided medical records indicate that impingement noted at the time of revision with notching of the neck, while excessive levels of chromium and cobalt could not be confirmed.The exact cause of the event could not be determined.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MODULAR DUAL MOBILITY INSERT
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 13043006
• Report Number: 0002249697-2021-02068
• Device Sequence Number: 5436634
• Product Code: LZO
• UDI-Device Identifier: 04546540666024
• UDI-Public: 04546540666024
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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: 09/30/2018
• Device Model Number: 626-00-46F
• Device Catalogue Number: 626-00-46F
• Device Lot Number: 45123401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2013
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male