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	Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Pain (1994); Metal Related Pathology (4530)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.
Event or Problem Description
Head liner exchange to f 44mm x3, -2.5 44mm biolox.Explanted 626-00-46f lot 80101203.Patient started complaining 6 months ago.Elevated ions.Patient was having pain.
Event or Problem Description
Head liner exchange to f 44mm x3, -2.5 44mm biolox.Explanted 626-00-46f lot 80101203.Patient started complaining 6 months ago.Elevated ions.Patient was having pain.
Additional Manufacturer Narrative
An event regarding abnormal ion level involving a mdm liner was reported.The event was not confirmed.Method & results: -product evaluation and results: visual inspection: visual inspection of the returned device was performed.Signs of implantation were present on the device with some nick/dents also present on the liner possibly as a result of explantation.Nothing remarkable was evident on the device.-clinician review: a review of the provided medical information by a clinical consultant indicated: "although undated the first x-ray shows a pressfit tha with what appears to be a 36mm femoral head.The components are in anatomic position and there is no evidence of loosening or mechanical complication.The second x-ray also undated shows the stem and shell of a pressfit tha in a similar position as tin the first x-ray.There is now a larger femoral head consistent with the event description.The two photographs of the acetabular shell show bits of blackened tissue consistent with metallosis.Following review of these records revision tha can be confirmed.The root cause for the patient's pain can not be established from the limited documentation provided.No information was provided to confirm the presence of elevated serum ions." -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 and elevated ion levels.Visual inspection of the returned device was performed.Signs of implantation were present on the device with some nick/dents also present on the liner possibly as a result of explantation.Nothing remarkable was evident on the device.Review of the provided medical records by a clinical consultant indicated, "following review of these records revision tha can be confirmed.The root cause for the patient's pain can not be established from the limited documentation provided.No information was provided to confirm the presence of elevated serum ions." the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, the primary/revision operative reports as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If additional information becomes 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: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13474327
• Report Number: 0002249697-2022-00199
• Device Sequence Number: 3886393
• Product Code: LZO
• UDI-Device Identifier: 04546540666024
• UDI-Public: 04546540666024
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K103233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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: 09/30/2025
• Device Model Number: 626-00-46F
• Device Catalogue Number: 626-00-46F
• Device Lot Number: 80101203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2020
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 57 KG