MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TRITANIUM HEMISPHERICAL SOLID BACK SHELL 58F; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_SHC

Device Problem Loss of Osseointegration (2408)

Patient Problems Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); Metal Related Pathology (4530)

Event Date 10/16/2023

Event Type  Injury  

Manufacturer Narrative

The following device was also listed in this report: device; unknown - trident x3 0° polyethylene insert 36f; cat# unknown ; lot# unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding loosening and infection involving an unknown trident shell was reported.The event 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.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to pain, elevated cobalt ion levels, infected left hip with trunnionosis and loose acetabular component.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned to the manufacturer.

Event Description

It is reported by counsel that claimant underwent left tha on (b)(6) 2014, and was implanted with an accolade ii hip stem and a lfit anatomic v40 femoral head.He was revised on (b)(6) 2021, allegedly due to pain, elevated cobalt ion levels, infected left hip with trunnionosis and loose acetabular component.

• Brand Name: TRITANIUM HEMISPHERICAL SOLID BACK SHELL 58F
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18098611
• MDR Text Key: 327698737
• Report Number: 0002249697-2023-01376
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/09/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male