MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ALUMINA 36 +5 HEAD; HIP IMPLANT

Catalog Number UNK_SHC

Device Problem Material Deformation (2976)

Patient Problems Irritation (1941); Tissue Damage (2104); Injury (2348)

Event Date 11/10/2008

Event Type  Injury  

Manufacturer Narrative

An event regarding wear of an unknown ceramic head identified upon explantation was reported.The event was not confirmed.Method and results: device evaluation and results: not performed as product was not returned medical records received and evaluation: review of these records confirms a revision of the patients left tha occurred in 2008 for iliopsoas tendinitis following a motor vehicle accident.No loosening or mechanical complication related to the implants was identified.The root cause of these complaints and revision tha cannot be determined as insufficient information was available.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: review of the medical records provided confirm a revision of the patients left tha occurred in 2008 for iliopsoas tendinitis following a motor vehicle accident.No loosening or mechanical complication related to the implants was identified.The root cause of these complaint and revision tha cannot be determined as insufficient information was available.The wear reported on the ceramic head could not be confirmed as the device was not returned for evaluation/images were not provided there is potential that the "stripe wear" reported could be a result of explantation damage, however, this cannot be confirmed.The exact cause of the event could not be determined because insufficient information was provided.Additional information, including operative notes, surgical implant records from the 2018 revision surgery, dated pre and post op x-rays/ imaging from the index and revision surgeries and implant retrieval are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.Not returned.

Event Description

Rep provided an operative note outlining the revision of patient's left hip after patient was involved in a motor vehicle accident and developed "persistent activity related symptoms to suggest anterior irritation of soft tissue structure including iliopsoas tendinitis".The head and liner were explanted with "some stripe wear" noted on the femoral head.Though surgeon stated "the underlying cup appeared stable and appropriately positioned", surgeon decided to "medialize a new cup" and revised it to a larger shell and size g poly insert.Patient was also revised to a delta ceramic 40 +4 head with sleeve.

• Brand Name: UNKNOWN ALUMINA 36 +5 HEAD
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: brad curtis ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7886679
• MDR Text Key: 120691248
• Report Number: 0002249697-2018-02938
• Device Sequence Number: 1
• Product Code: JDI
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/18/2018
• 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: 44 YR
• Patient Weight: 112