MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 28 +4 METAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_JR

Device Problem Degraded (1153)

Patient Problem Metal Related Pathology (4530)

Event Date 04/02/2024

Event Type  Injury  

Manufacturer Narrative

An event regarding wear involving an unknown metal head 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.The photographs show a recently explanted metal head with nothing remarkable to note.From the photographs provided there is no evidence of wear for the device.-clinician review: no medical records were provided for review.-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 metallosis.The reported device was not returned however photographs were provided for review.The photographs show a recently explanted metal head with nothing remarkable to note.From the photographs provided there is no evidence of wear for the device.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device identification details and return of the device 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 : not returned.

Event Description

It was reported that the patient's left hip was revised due to metallosis.Intra-operatively, it was noted that the head had worn through the liner and the head was articulating against the shell.The shell, liner, and head were revised to competitor acetabular components with a stryker ceramic head.Rep provided explant pictures and confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: UNKNOWN 28 +4 METAL HEAD
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19190713
• MDR Text Key: 341128546
• Report Number: 0002249697-2024-00654
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• 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): Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male