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

Model Number	0580-1-352
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Joint Dislocation (2374); Insufficient Information (4580)
Date of Event	04/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As per rep: "it was a revision hip.We removed an exeter stem which was a 37.5 no.0".
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.
Additional Manufacturer Narrative
Reported event: an event regarding revision involving a exeter stem was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs show a recently explanted stem.No obvious damage is visible but as the stem is covered in blood/tissue, no conclusions can be determined from the photographs.Clinician review: no medical records were received for review with a clinical consultant.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 exeter stem was explanted but the reason for revision was not reported or evident from the photographs of the explanted device that were provided.The explantation of the stem from the patient can be confirmed but a device failure mode could not be determined from the information provided.It was further reported that the device was subsequently re-implanted into the patient after it was explanted.As stated in the ifu associated with this product family, "single use devices cannot be explanted and subsequently reimplanted as the physical forces exerted by these actions may compromise the physical integrity, dimensions and/or surface finishes of the devices." this is an off-label application.Further information such as pathology reports, pre- and post-operative x-rays 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 additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As per rep: "it was a revision hip.We removed an exeter stem which was a 37.5 no.0" update: patient was revised due to dislocation between stem and head.

• 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: arokiya raj ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16982493
• Report Number: 0002249697-2023-00574
• Device Sequence Number: 12435802
• Product Code: LPH
• UDI-Device Identifier: 04546540153241
• UDI-Public: 04546540153241
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K011623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: 0580-1-352
• Device Catalogue Number: 0580-1-352
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 70 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White