MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_40 +4 METAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNK_JR

Device Problems Corroded (1131); Material Erosion (1214); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body Reaction (1868); Ambulation Difficulties (2544)

Event Date 07/07/2023

Event Type  Injury  

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.Device not returned.

Event Description

It was reported that the patient's right hip was revised due to dissociation of the head from the stem.Intra-operatively, black tissue and trunnion wear were noted.The stem, head and liner were revised to a restoration modular stem construct with a 36 ceramic head and 36 poly liner.Rep confirmed that there were no allegations against the revised liner, and that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding disassociation and altr involving an lfit v40 cocr head that was mated with an unknown accolade stem was reported.The event for disassociation was confirmed via medical review.Altr 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: a review of the provided medical records by a clinical consultant concluded: 'this inquiry concerns a (b)(6) female who underwent a primary right cementless total hip arthroplasty in 2008 and developed head neck disassociation with trunnion and femoral component deformity which necessitated revision on (b)(6) 2023.The root cause of this event cannot be determined with certainty.The causes of head/neck disassociation with associated findings are multifactorial including surgical technique factors including possible impingement, patient factors such as activity level and bmi, and implant factors.The deformity seen on the x-ray of the trunnion and the medial aspect of the femoral prosthesis could indicate impingement.The revision surgery took place on (b)(6) 2023.The explanted prosthesis should be submitted to stryker engineers for evaluation and analysis.' product history review: a review of the device history records could not be performed as no lot information was provided.Complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: it was reported that the patient was revised due to dissociation of the head from the stem.A review of the provided medical records by a clinical consultant concluded: 'this inquiry concerns a (b)(6) female who underwent a primary right cementless total hip arthroplasty in 2008 and developed head neck disassociation with trunnion and femoral component deformity which necessitated revision on (b)(6) 2023.The root cause of this event cannot be determined with certainty.The causes of head/neck disassociation with associated findings are multifactorial including surgical technique factors including possible impingement, patient factors such as activity level and bmi, and implant factors.The deformity seen on the x-ray of the trunnion and the medial aspect of the femoral prosthesis could indicate impingement.The revision surgery took place on (b)(6) 2023.The explanted prosthesis should be submitted to stryker engineers for evaluation and analysis.' further information such as lot details, device return, primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.

Event Description

It was reported that the patient's right hip was revised due to dissociation of the head from the stem.Intra-operatively, black tissue and trunnion wear were noted.The stem, head and liner were revised to a restoration modular stem construct with a 36 ceramic head and 36 poly liner.Rep confirmed that there were no allegations against the revised liner, and that no further information will be released by the hospital or surgeon.

• Brand Name: UNKNOWN_40 +4 METAL 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17393307
• MDR Text Key: 319829931
• Report Number: 0002249697-2023-00835
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

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: 07/07/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 09/07/2023
• 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: 91 YR
• Patient Sex: Female
• Patient Weight: 61 KG