MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PRIMARY TRITANIUM HEMI SOLIDBACK CUP 54MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number 500-03-54E

Device Problems Malposition of Device (2616); Unintended Movement (3026)

Patient Problems Ambulation Difficulties (2544); Insufficient Information (4580)

Event Date 04/11/2022

Event Type  Injury  

Event Description

This pi is for the patient's right hip, which has been revised.It was reported that the patient has bilateral stryker hips.The acetabular shells for both sides have 'spun out' and are now oriented vertically and retroverted.Patient's right hip was revised on (b)(6) 2022 (shell, head and liner were revised.Rep confirmed there are no allegations against the revised head or liner).The surgeon plans to revise the patient's left hip, date currently unknown.

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 review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.Device not returned.

Event Description

This pi is for the patient's right hip, which has been revised.It was reported that the patient has bilateral stryker hips.The acetabular shells for both sides have 'spun out' and are now oriented vertically and retroverted.Patient's right hip was revised on (b)(6) 2022 (shell, head and liner were revised.Rep confirmed there are no allegations against the revised head or liner).The surgeon plans to revise the patient's left hip, date currently unknown.

Manufacturer Narrative

Reported event an event regarding malposition involving an trident shell was reported.The event was not confirmed.Method & results -product evaluation and results: visual inspection: visual inspection: visual inspection of the shell shows bone and tissue residue consistent with being implanted for a period of time.Visual inspection of the head and liner show scratches consistent with explantation.Material analysis, functional and dimensional inspections were not performed as these aspects were not in question.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the 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.

• Brand Name: PRIMARY TRITANIUM HEMI SOLIDBACK CUP 54MM
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 14321164
• MDR Text Key: 291232422
• Report Number: 0002249697-2022-00655
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327040012
• UDI-Public: 07613327040012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081171
• 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
• Report Date: 07/28/2022

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 Expiration Date: 04/30/2021
• Device Model Number: 500-03-54E
• Device Catalogue Number: 500-03-54E
• Device Lot Number: X12XYR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 07/06/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2016
• 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: 66 YR
• Patient Sex: Male