MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 52MM SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number UNK_JR

Device Problem Loss of Osseointegration (2408)

Patient Problem Inadequate Osseointegration (2646)

Event Date 01/29/2024

Event Type  Injury  

Event Description

It was reported that the patient's right hip was revised due to a failed shell.The shell had loosened, leading to impingement of the stem.The shell, head, and liner were revised to a multi-hole shell with screws, elevated rim liner, and femoral head.No allegations were made against the revised head.Rep can provide pictures, otherwise confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

An event regarding loosening involving an unknown shell ¿was reported.¿the event was not¿confirmed.¿¿¿ method & results:¿ -device evaluation and results: not performed as product 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 device details, 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 returned to the manufacturer.

• Brand Name: UNKNOWN 52MM SHELL
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18737368
• MDR Text Key: 335705828
• Report Number: 0002249697-2024-00260
• 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: 02/20/2024

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_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/20/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female