MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 37.5MM NO 0; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number	0580-1-352
Medical Device Problem Codes	Loss of Osseointegration (2408); Failure to Advance (2524)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the rep: "the patient had an exeter stem in situ; the surgeon did not have any details on the size of the exeter stem as was not able to ascertain previous op notes from the hospital it was done at.Only info he had was the patient was done around 8 years ago.The original plan was to just change the head on the stem, but on knocking the head off the stem came out with it.The surgeon checked the size of the exeter stem by reading the side which showed 37.5 0.He asked for a new stem the same size to reput in, we got a 37.5 0 to reput in but it would not fit proximally it was too big.Surgeon resorted to using previous stem that was already in situ which fit as expected.".
Additional Manufacturer Narrative
Reported event: an event regarding assembly issue involving an exeter stem was reported.The event was not confirmed method & results: -product evaluation and results: visual inspection: visual inspection of the returned device indicates nothing remarkable to report.Dimensional inspection: the device is dimensionally within specification as per inspection completed by qa manufacturing engineer.Functional inspection: not performed as the functional aspects are not in question.Material analysis: not performed as this event does not relate to material integrity.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the product history records indicate the reported device was manufactured with no reported relevant discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that 'as reported by the rep: "the patient had an exeter stem in situ, the surgeon did not have any details on the size of the exeter stem as was not able to ascertain previous op notes from the hospital it was done at.Only info he had was the patient was done in plymouth around 8 years ago.The original plan was to just change the head on the stem, but on knocking the head off the stem came out with it.The surgeon checked the size of the exeter stem by reading the side which showed 37.5 0.He asked for a new stem the same size to reput in, we got a 37.5 0 to reput in but it would not fit proximally it was too big.Surgeon resorted to using previous stem that was already in situ which fit as expected." the device is dimensionally within specification as per inspection completed by qa manufacturing engineer.The exact cause of the event could not be determined because insufficient information was provided.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
No new information.

• Brand Name: EXETER V40 STEM 37.5MM NO 0
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23059245
• Report Number: 0002249697-2025-00979
• Device Sequence Number: 12906933
• Product Code: LPH
• UDI-Device Identifier: 04546540153241
• UDI-Public: 04546540153241
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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 Catalogue Number: 0580-1-352
• Device Lot Number: G8754524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2024
• 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 Sex: Unknown