MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_ADM/ MDM POLY INSERT; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_SHC

Device Problem Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 05/09/2022

Event Type  Injury  

Event Description

This pi is for the revision of the patient's right hip on (b)(6) 2022 (though outside of cors scope, the revised implants were named).Patient had an index right tha outside of cors scope.The patient was revised for squeaking on (b)(6) 2022.Only the mdm liner and head were exchanged.The patient develops pji requiring a second right tha revision on (b)(6) 2022.Only the mdm liner and head were exchanged.

Manufacturer Narrative

Reported event: an event regarding audible noise involving an unknown adm liner was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : not available.

• Brand Name: UNKNOWN_ADM/ MDM POLY INSERT
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16929869
• MDR Text Key: 315194638
• Report Number: 0002249697-2023-00520
• 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: 05/15/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2023
• Initial Date FDA Received: 05/15/2023
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 113 KG