MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_36 +10 METAL HEAD; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number UNK_JR

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

Patient Problems Foreign Body Reaction (1868); Insufficient Information (4580)

Event Date 07/25/2023

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.H3 other text : device not returned.

Event Description

It was reported that the patient's right hip was revised due to dissociation of the femoral head from the stem.Intra-operatively, trunnion wear and black tissue were noted.The stem, head, and liner were revised (there are no allegations against the revised liner).Rep can provide pictures and otherwise confirmed that no further information will be released by the hospital or surgeon.

Manufacturer Narrative

Reported event: an event regarding disassociation involving 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: "conclusion/assessment: a metallic 36mm +10mm head dissociated from an accolade tmzf stem.An xray showed severe trunnion wear and the dissociation.Event confirmation: the head dissociation and trunnion wear can be confirmed.The revision surgery and findings at surgery cannot be confirmed.Root cause: the root cause of the head dissociation was trunnion wear.The etiology of the trunnion wear may be investigated via lot numbers." 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 disassociation of the femoral head from the stem.A review of the provided medical information by a clinical consultant indicated: "conclusion/assessment: a metallic 36mm +10mm head dissociated from an accolade tmzf stem.An xray showed severe trunnion wear and the dissociation.Event confirmation: the head dissociation and trunnion wear can be confirmed.The revision surgery and findings at surgery cannot be confirmed.Root cause: the root cause of the head dissociation was trunnion wear.The etiology of the trunnion wear may be investigated via lot numbers." further information such as device-identifying details (catalog and lot code), return of the devices, and the revision 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.

Event Description

It was reported that the patient's right hip was revised due to dissociation of the femoral head from the stem.Intra-operatively, trunnion wear and black tissue were noted.The stem, head, and liner were revised (there are no allegations against the revised liner).Rep can provide pictures and otherwise confirmed that no further information will be released by the hospital or surgeon.

• Brand Name: UNKNOWN_36 +10 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 17585466
• MDR Text Key: 321552480
• Report Number: 0002249697-2023-00906
• 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: 10/24/2023

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: 07/25/2023
• Initial Date FDA Received: 08/21/2023
• Supplement Dates Manufacturer Received: 09/30/2023
• Supplement Dates FDA Received: 10/24/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male