MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 35.5MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Model Number	0580-1-351
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	05/18/2020
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
Revision hip surgery required on a patient due to implant cracking.Stryker exeter stem broke in the patients femur after being implanted in 2003.We removed the broken stem and replaced it with a cement in cement revision stem.Patient came in with pain to hip.Picked up on x-ray.
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving exeter stem was reported.The event was confirmed based on medical review.Method & results: -device evaluation and results:visual inspection: the reported device was not returned however photographs were provided for review and it can be observed that femoral stem is broken.Material analysis, functional and dimensional inspections could not be performed as the device was not returned.  -clinician review:a review of the provided medical records by a clinical consultant was rejected and stated the following comment:a color photo of a blood stained explanted intact ceramic modular head with 2 dark lines on the articular surface.A photo of an explanted broken femoral stem on an extractor.Undated ap x-ray of left hip - hybrid tha with ceramic head reduced, transverse fracture of stem at junction of mid and distal 1/3 with varus displacement of proximal fragment.No clinical or pmh, no patient demographics, no operative reports, no examination of explanted components.X-ray confirms event description, but insufficient data presented 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: it was reported that revision hip surgery required on a patient due to implant cracking.The event was confirmed based on medical review.A review of the provided medical records by a clinical consultant was rejected and stated the following comment: a color photo of a blood stained explanted intact ceramic modular head with 2 dark lines on the articular surface.A photo of an explanted broken femoral stem on an extractor.Undated ap x-ray of left hip - hybrid tha with ceramic head reduced, transverse fracture of stem at junction of mid and distal 1/3 with varus displacement of proximal fragment.No clinical or pmh, no patient demographics, no operative reports, no examination of explanted components.X-ray confirms event description, but insufficient data presented to create a medical report for this case.The exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not returned.
Event or Problem Description
Revision hip surgery required on a patient due to implant cracking.Stryker exeter stem broke in the patients femur after being implanted in 2003.We removed the broken stem and replaced it with a cement in cement revision stem.Patient came in with pain to hip.Picked up on x-ray.

• Brand Name: EXETER V40 STEM 35.5MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10139482
• Report Number: 0002249697-2020-01133
• Device Sequence Number: 2115540
• Product Code: JDI
• UDI-Device Identifier: 04546540153234
• UDI-Public: 04546540153234
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2020

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: 0580-1-351
• Device Catalogue Number: 0580-1-351
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 66 YR