MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 3; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-1-443
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/01/2021
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
(b)(6)-yr old male had a fall backwards.X-ray showed his right femoral stem was in two pieces.Revision surgery was required.44mm#3 exeter stem was removed and replaced with another into existing cement mantle.Operating surgeon commented that the 36mm +5 femoral head appeared to be ¿twisted and stuck¿ inside the acetabular component and he commented that he believes the stem broke at the neck as a result of the mechanism of the fall.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed through visual inspection of the returned device and clinician review of the provided medical records.Method & results: -product evaluation and results: visual inspection of the returned device showed that the stem has fractured just below the trunnion.Material analysis: visual inspection of the returned device showed that the stem has fractured just below the trunnion and away from any interaction with the femoral head.It was reported in the event that the patient suffered a fall.The fracture of the device is consistent with a fall and therefore, no further material analysis is required at this time.-clinician review: a review of the provided medical records by a clinical consultant stated the following comment: re pi which is from australia and represents a (b)(6) patient described as 188 cm tall and weighing 103 kg whose date of implantation is listed as (b)(6) 2009 and explantation (b)(6) 2021.The event description states: ".X-ray showed.Right femoral stem.In 2 pieces.#3 cemented exeter.Replaced with another.Into existing cement mantle." (b)(6) 2009 brief operative report: right thr.Diagnosis osteoarthritis right hip.Cemented #3 exeter.36/+5 head, uncemented 66 cluster trident cup.Flat liner." uncomplicated surgery.Undated x-ray : ap pelvis - bilateral hybrid tha left reduced and nominal, right displaced transverse fracture of prosthetic stem at base of trunnion with prosthetic head remaining in acetabular component.No clinical or pmh, no revision operative report, no dated serial x-rays, no examination of explanted components.Based upon the x-ray provided, the event description appears to be confirmed, but insufficient data is available to create a medical report for this case.-device history review: could not be performed as lot code information was not provided.-complaint history review: could not be performed as lot code information was not provided.Conclusion: visual inspection of the returned device showed that the stem has fractured just below the trunnion and away from any interaction with the femoral head.It was reported in the event that the patient suffered a fall.The fracture of the device is consistent with a fall and therefore, no further material analysis is required at this time.A review of the provided medical records by a clinical consultant stated the following comment: re pi which is from australia and represents a (b)(6) patient described as 188 cm tall and weighing 103 kg whose date of implantation is listed as (b)(6) 2009 and explantation (b)(6) 2021.The event description states: ".X-ray showed.Right femoral stem.In 2 pieces.#3 cemented exeter.Replaced with another.Into existing cement mantle." (b)(6) 2009 brief operative report: right thr.Diagnosis osteoarthritis right hip.Cemented #3 exeter.36/+5 head, uncemented 66 cluster trident cup.Flat liner." uncomplicated surgery.Undated x-ray : ap pelvis - bilateral hybrid tha left reduced and nominal, right displaced transverse fracture of prosthetic stem at base of trunnion with prosthetic head remaining in acetabular component.No clinical or pmh, no revision operative report, no dated serial x-rays, no examination of explanted components.Based upon the x-ray provided, the event description appears to be confirmed, but insufficient data is available to create a medical report for this case.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
(b)(6) had a fall backwards.X-ray showed his right femoral stem was in two pieces.Revision surgery was required.44mm#3 exeter stem was removed and replaced with another into existing cement mantle.Operating surgeon commented that the 36mm +5 femoral head appeared to be ¿twisted and stuck¿ inside the acetabular component and he commented that he believes the stem broke at the neck as a result of the mechanism of the fall.

• Brand Name: EXETER V40 STEM 44MM NO 3
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 11581244
• Report Number: 0002249697-2021-00554
• Device Sequence Number: 14664020
• Product Code: JDI
• UDI-Device Identifier: 04546540153326
• UDI-Public: 04546540153326
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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: 0580-1-443
• Device Catalogue Number: 0580-1-443
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 05/23/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 103 KG