MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	502-03-52D
Medical Device Problem Codes	Degraded (1153); Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Inadequate Osseointegration (2646)
Date of Event	10/05/2022
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.
Event or Problem Description
It was reported that the patient's right hip was revised due to shell loosening.Intra-operatively, black tissue was noted in the patient's joint.A shell, 2 screws, liner and head were revised.Rep confirmed there are no allegations against the revised liner.
Additional Manufacturer Narrative
Reported event: an event regarding loosening and wear/metallosis involving a trident shell was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.Visual inspection of the provided photograph indicated that the device was recently explanted.Blood, tissue, and bone residue are visible on the bone-interfacing surfaces of the device.Nothing further remarkable is observed.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 shell loosening and intraoperatively black tissue was observed in the hip joint.The reported device was not returned however photographs were provided for review.Visual inspection of the provided photograph indicated that the device was recently explanted.Blood, tissue, and bone residue are visible on the bone-interfacing surfaces of the device.Nothing further remarkable is observed.The exact cause of the event could not be determined because insufficient information was provided.Further information such as 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.
Event or Problem Description
It was reported that the patient's right hip was revised due to shell loosening.Intra-operatively, black tissue was noted in the patient's joint.A shell, 2 screws, liner and head were revised.Rep confirmed there are no allegations against the revised liner.

• Brand Name: PRIMARY TRITANIUM HEMI CLUSTER HOLE CUP 52MM
• Common Device Name: 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 15672254
• Report Number: 0002249697-2022-01551
• Device Sequence Number: 6372672
• Product Code: LPH
• UDI-Device Identifier: 07613327040128
• UDI-Public: 07613327040128
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K143085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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 Model Number: 502-03-52D
• Device Catalogue Number: 502-03-52D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female