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

Catalog Number UNK_JR

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/08/2023

Event Type  Injury  

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.H3 other text : not returned.

Event Description

It was reported through the submission of a revision usage sheet that the patient's hip was revised.A restoration modular stem construct, ceramic head, adm/ mdm poly insert, and mdm metal liner were implanted.

Manufacturer Narrative

Corrected data: product long description.An event regarding fracture involving an unknown stem was reported.The event for broken trunnion was confirmed through medical review.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: the x-ray provided demonstrates a pressfit tha.The trunnion has fractured and the head has dissociated.While the event depicted in the x-ray would require revision surgery no information was provided that would confirm that this surgery did occur.The root cause of the trunnion fracture cannot be determined by the limited information provided.-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 had to be revised due to broken stem trunnion.A review of the provided medical records by a clinical consultant indicated: "the x-ray provided demonstrates a pressfit tha.The trunnion has fractured and the head has dissociated.While the event depicted in the x-ray would require revision surgery no information was provided that would confirm that this surgery did occur.The root cause of the trunnion fracture cannot be determined by the limited information provided." 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.

Event Description

It was reported through the submission of a revision usage sheet that the patient's hip was revised.A restoration modular stem construct, ceramic head, adm/ mdm poly insert, and mdm metal liner were implanted.Update: trunnion on the existing stem had failed and broken off.

• Brand Name: UNKNOWN STRYKER STEM
• 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: 17020730
• MDR Text Key: 316205522
• Report Number: 0002249697-2023-00601
• 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,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• 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: 06/22/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male