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

Catalog Number UNK_JR

Device Problems Loss of Osseointegration (2408); Malposition of Device (2616); Osseointegration Problem (3003)

Patient Problem Inadequate Osseointegration (2646)

Event Date 07/12/2022

Event Type  Injury  

Event Description

A patient specific implant request was received for the patient's right hip.Noted on the form: "progression since 2019 acetabular cup in vertical orientation.Single screw with tip into the iliacus muscle.Lucency surrounding the component, lucency in acetabular measurement up to 6mm." planned surgery date (b)(6) 2022.

Manufacturer Narrative

It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.

Event Description

A patient specific implant request was received for the patient's right hip.Noted on the form: "progression since 2019 acetabular cup in vertical orientation.Single screw with tip into the iliacus muscle.Lucency surrounding the component, lucency in acetabular measurement up to 6mm." planned surgery date (b)(6) 2022.

Manufacturer Narrative

Explant date added to d6b.Reported event: an event regarding loosening and malposition involving an unknown trident 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 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.

Manufacturer Narrative

D6b - explant date updated.Reported event: an event regarding loosening and malposition involving an unknown trident 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 event could not be confirmed as insufficient information was provided.Further information such as device identification and return, pre- and post-operative x-rays, primary 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 additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

A patient specific implant request was received for the patient's right hip.Noted on the form: "progression since 2019 acetabular cup in vertical orientation.Single screw with tip into the iliacus muscle.Lucency surrounding the component, lucency in acetabular measurement up to 6mm." planned surgery date (b)(6) 2022.

• Brand Name: UNKNOWN_ACETABULAR 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 15137288
• MDR Text Key: 296952302
• Report Number: 0002249697-2022-01109
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2023

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_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/01/2022
• Supplement Dates Manufacturer Received: 10/05/2022; 12/22/2022
• Supplement Dates FDA Received: 10/29/2022; 01/17/2023
• 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: 71 YR
• Patient Sex: Female
• Patient Weight: 61 KG