MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 30MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	0580-1-300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Fall (1848)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
Patient falls and goes to the hospital.X-rays revealed a broken stem.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device indicated that plastic surface deformation consistent with micro-motion at the stem-cement interface was observed on the surfaces of the stem.This abrasion is indicative of cyclic stress-strain consistent with fatigue fracture of the stem.Clinician review: a review of the provided medical information by a clinical consultant indicated: "this patient sustained a fracture of her left total hip arthroplasty femoral stem after a fall, about 17 years after implantation, necessitating revision surgery.I can confirm that the fracture occurred since i was able to review the x-rays showing the fracture.I cannot confirm with certainty that the revision occurred, since i don't have any supporting documentation including office notes, operation report, or an x-ray after revision surgery.However, the summary does report that the original implant was explanted on (b)(6) 2022.I cannot determine the root cause with certainty.There is no mention that the patient had any symptoms before the fall so i would most likely have to assign causality to the trauma.Other causes of fracture of the femoral stem include surgical technique factors such as cement technique, patient factors such as bmi and activity level, as well as implant factors." product history review: a review of the stryker database and legacy systems indicated dhr information is unavailable.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to fracture of the exeter stem following a fall.Visual inspection of the returned device indicated that plastic surface deformation consistent with micro-motion at the stem-cement interface was observed on the surfaces of the stem.This abrasion is indicative of cyclic stress-strain consistent with fatigue fracture of the stem.The event was further confirmed through clinician review of the provided x-ray image.It was reported that the patient sustained a fall prior to device failure, so it is likely that this patient trauma contributed to the event.No further investigation for this event is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
Patient falls and goes to the hospital.X-rays revealed a broken stem.

• Brand Name: EXETER V40 STEM 30MM
• 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: diana rogers ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; UK WD6 3SJ ; 2082386500
• MDR Report Key: 15346714
• Report Number: 0002249697-2022-01295
• Device Sequence Number: 12069970
• Product Code: LPH
• UDI-Device Identifier: 04546540153210
• UDI-Public: 04546540153210
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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
• Operator of Device: Health Professional
• Device Model Number: 0580-1-300
• Device Catalogue Number: 0580-1-300
• Device Lot Number: GZB19110
• 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: 08/15/2022
• Supplement Date Received by Manufacturer: 02/25/2023
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Female