MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ALUMINA C-TAPER HEAD 36MM/0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number	17-3600E
Medical Device Problem Codes	Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	06/08/2021
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.
Event or Problem Description
It was reported that the patient required revision hip surgery following identification of elevated ti levels and a worn (titanium sleeve portion) of a ceramic liner had to be removed in addition to an alumina head.It was further reported that the patient was revised using a new poly liner coupled with a c taper sleeve and delta 36mm head.
Event or Problem Description
It was reported that the patient required revision hip surgery following identification of elevated ti levels and a worn (titanium sleeve portion) of a ceramic liner had to be removed in addition to an alumina head.It was further reported that the patient was revised using a new poly liner coupled with a c taper sleeve and delta 36mm head.
Additional Manufacturer Narrative
Alumina c-taper head has been deemed concomitant.Reported event: an event regarding wear (metallosis) and abnormal ion level involving a ceramic head was reported.Conclusion: based on the information provided there is no indication or allegation that the device reported in this investigation contributed to the event and is therefore considered concomitant.The patient was revised due to ¿elevated ti levels and a worn (titanium sleeve portion) of a ceramic liner.¿ there were no reported allegations against the ceramic head as it has no metal components, and it was only explanted as the mating trident liner required revision.A full investigation is completed on the trident liner.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: ALUMINA C-TAPER HEAD 36MM/0
• 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 NJ NA ; EI NA
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12104518
• Report Number: 0002249697-2021-01123
• Device Sequence Number: 11707835
• Product Code: LZO
• UDI-Device Identifier: 07613327101270
• UDI-Public: 07613327101270
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K991952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022
• 2 Devices were Involved in the Event: 1 2

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 Model Number: 17-3600E
• Device Catalogue Number: 17-3600E
• Device Lot Number: 06C187554
• 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: 06/08/2021
• Supplement Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Female