MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN 44 +0 LFIT COCR FEMORAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNK_JR

Device Problems Degraded (1153); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Metal Related Pathology (4530)

Event Date 04/17/2023

Event Type  Injury  

Manufacturer Narrative

Reported event: an event regarding disassociation and wear of an unknown metal head was reported.The event was confirmed via clinician review of the provided medical records.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 information by a clinical consultant indicated: this product inquiry concerns an 83-year-old gentleman who underwent a left total hip arthroplasty on (b)(6) 2013.On (b)(6) 2023, he underwent a revision of that total hip arthroplasty due to head and neck disassociation with trunnion wear and liner wear and damage.I can confirm that this event occurred since i was able to see an x-ray with the head neck disassociation.Having said that, no demographic markings were present on the x-ray.In the product inquiry summary it states that a revision was carried out.I cannot confirm that for certain because i have no supporting documentation such as office notes, operation reports or photographs.I cannot determine the root cause of this event with certainty.Causes of head neck disassociation with trunnion wear and deformity, liner damage and wear, with black tissue findings are multifactorial.These include surgical technique factors, patient activity factors such as bmi and activity level and implant factors.The implants that were revised should be submitted to stryker engineers for their evaluation and examination.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to pain and head and stem disassociation.During revision excessive trunnion wear was noted, as well as, black tissue in the patient, liner wear/ damage.The event was confirmed via clinician review of the provided medical records, but the root cause could not be determined from the information provided: i cannot determine the root cause of this event with certainty.Causes of head neck disassociation with trunnion wear and deformity, liner damage and wear, with black tissue findings are multifactorial.These include surgical technique factors, patient activity factors such as bmi and activity level and implant factors.H3 other text : device not returned.

Event Description

It was reported that the patient's left hip was revised after patient complaint of pain.Pre- and intra-operatively, the following were noted: head dissociation, excessive trunnion wear, black tissue in the patient, liner wear/ damage.Though the stem was not reported as loose, it was reported that it came out more easily than expected.The stem, head and liner were revised to a 10° poly liner and competitor femoral components.

• Brand Name: UNKNOWN 44 +0 LFIT COCR FEMORAL 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 16901031
• MDR Text Key: 314887217
• Report Number: 0002249697-2023-00494
• 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
• Report Date: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• 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
• Date Manufacturer Received: 04/17/2023
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 102 KG