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

Model Number	0580-1-352
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, "revised an exeter/mitch combination this morning".This pi is for the right hip.
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.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.The mitch trh acetabular system components are oem devices.Stryker orthopaedics is not the legal manufacturer of the mitch devices and does not have reporting responsibilities.However, since this device was used in conjunction with a stryker device they are being listed as associated devices.Cat # mac-9988-4652; lot # fm061600; description: std mitch trh cp sz 46/52; manufacturer: depuy.Cat # mmh-9988-0446; lot # fm070216; description: mitch trh md hd sz 46-4; manufacturer: depuy.
Additional Manufacturer Narrative
Reported event: an event regarding revision involving an exeter stem was reported.The event was not confirmed.Method & results:  device evaluation and results: visual inspection of the device indicated that the device was returned in used condition.Scratches were observed on the device.This damage is consistent with time spent implanted in the body in contact with cement, followed by attempted explantation.No further surface discrepancies were observed.Clinician review: no medical records were received for review with a clinical consultant .Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.  conclusion: visual inspection of the device indicated that the device was returned in used condition.Scratches were observed on the device.This damage is consistent with time spent implanted in the body in contact with cement, followed by attempted explantation.No further surface discrepancies were observed.The event could not be confirmed as insufficient information was provided.Further information such as pre- and post-operative x-rays, primary 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 become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported, "revised an exeter/mitch combination this morning".This pi is for the right hip.

• Brand Name: EXETER V40 STEM 37.5MM NO 0
• 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: 15707304
• Report Number: 0002249697-2022-01577
• Device Sequence Number: 5144821
• Product Code: JDI
• 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
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2023

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 Expiration Date: 09/30/2012
• Device Model Number: 0580-1-352
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G2005370
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2007
• 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: 67 YR
• Patient Sex: Female