MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 22.2MM +8 LFIT V40 HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number 6260-9-322

Device Problem Mechanical Problem (1384)

Patient Problem Ambulation Difficulties (2544)

Event Date 02/24/2022

Event Type  Injury  

Event Description

This pi is for revision of the patient's left hip on (b)(6) 2022.While providing information for revision of the patient's left hip on (b)(6) 2022, rep provided a usage sheet from a prior revision on (b)(6) 2022.Reporting rep was not present for the procedure, but a stryker rep was present.Patient was revised due to dissociation of the constrained liner from the shell.Surgeon decided that the patient did not have enough offset.A restoration modular proximal body (implanted (b)(6) 2020), and a constrained liner and femoral head (implanted (b)(6) 2021) were revised.The shell (implanted (b)(6) 2020) was not revised.Rep confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding incorrect selection involving a metal head was reported.The event was not confirmed.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: 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: it was reported that the patient was revised due to disassociation of the liner from the shell.The surgeon also decided that the patient did not have enough offset and revised the restoration modular body and metal head.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 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 devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: 22.2MM +8 LFIT V40 HEAD
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: 15550341
• MDR Text Key: 301253373
• Report Number: 0002249697-2022-01445
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 07613327013092
• UDI-Public: 07613327013092
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121308
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 6260-9-322
• Device Catalogue Number: 6260-9-322
• Device Lot Number: 61698601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2017
• 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: 68 YR
• Patient Sex: Female