MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 2; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-1-442
Medical Device Problem Codes	Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Insufficient Information (4580)
Date of Event	02/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.H3 other text : not returned.
Event or Problem Description
As reported by the customer: "(b)(6) did a revision total hip replacement this morning and he took out an exeter stem which, according to him, has failed.He wants this stem/ implant to be sent for analysis." additional information: slipped on a wet floor (awkward twist not direct fall on to the hip).Revision operative report notes the pre-op diagnosis as periprosthetic fracture of right hip.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture and periprosthetic fracture involving an exeter stem was reported.The event of crack/fracture was confirmed via device evaluation.Periprosthetic fracture was not confirmed.Method & results: product evaluation and results: characterization using stereo microscopy and scanning electron microscopy confirmed fracture of the stem through the prehension hole due to fatigue, with final fracture in overload.Surface material damage was observed across the stem surfaces, indicating micromotion effects, due to cement mantle breakdown.No manufacturing or material related defects were observed on the device surfaces examined.Clinician review: a review of the provided medical information by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had a revision right total hip arthroplasty since i was able to review the operation report which occurred on february 5, 2024.I was not given any x-rays prior to the revision or after the revision.Root cause analysis: the root cause of this event cannot be determined with certainty.It appears that for some reason patient had a revision of the acetabular component of this total hip arthroplasty with a "cement in cement" acetabular revision and a revision of the femoral component, which was fractured, also with a "cement in cement" type procedure.I have no information about why the acetabular component was changed so i cannot comment on the root cause of the so-called failure.I also have no x-rays showing a fracture of the femoral component so i cannot analyze the possible causes.In general, causes of fracture of the femoral stem can be related to surgical technique, especially in the way that cementation was carried out in relation to the implant, patient lifestyle, activity level and bmi, and implant factors.Product history review: a review of the device history records for the exeter v40 stem 44mm no 2, indicates that devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: characterization using stereo microscopy and scanning electron microscopy confirmed fracture of the stem through the prehension hole due to fatigue, with final fracture in overload.Surface material damage was observed across the stem surfaces, indicating micromotion effects, due to cement mantle breakdown.No manufacturing or material related defects were observed on the device surfaces examined.A review of the provided medical information by a clinical consultant indicated: "confirmation of event: i can confirm that the patient had a revision right total hip arthroplasty since i was able to review the operation report which occurred on february 5, 2024.I was not given any x-rays prior to the revision or after the revision.Root cause analysis: the root cause of this event cannot be determined with certainty.It appears that for some reason patient had a revision of the acetabular component of this total hip arthroplasty with a "cement in cement" acetabular revision and a revision of the femoral component, which was fractured, also with a "cement in cement" type procedure.I have no information about why the acetabular component was changed so i cannot comment on the root cause of the so-called failure.I also have no x-rays showing a fracture of the femoral component so i cannot analyze the possible causes.In general, causes of fracture of the femoral stem can be related to surgical technique, especially in the way that cementation was carried out in relation to the implant, patient lifestyle, activity level and bmi, and implant factors.No further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported by the customer: "mr (b)(6) did a revision total hip replacement this morning and he took out an exeter stem which, according to him, has failed.He wants this stem/ implant to be sent for analysis." additional information: slipped on a wet floor (awkward twist not direct fall on to the hip).Revision operative report notes the pre-op diagnosis as periprosthetic fracture of right hip.

• Brand Name: EXETER V40 STEM 44MM NO 2
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: sanjana talathi ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18833889
• Report Number: 0002249697-2024-00341
• Device Sequence Number: 15317901
• Product Code: LPH
• UDI-Device Identifier: 04546540153319
• UDI-Public: 04546540153319
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2011
• Device Catalogue Number: 0580-1-442
• Device Lot Number: G1596038 44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2006
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female