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); Ambulation or Postural Difficulties (2544)
Date of Event	11/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient presented with pain in left hip.Upon x-ray a fracture of stem was noticed.
Additional Manufacturer Narrative
An event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via clinician review and mar.Method & results: product evaluation and results: the stem fractured in the main body and the proximal portion remained in the head.The direction of fracture propagation was determined with macroscopic surface features (beach marks) on the fracture surface associated with the proximal portion of the stem.The fracture originated on the lateral surface and propagated to the medial surface.Fatigue striations were observed which indicate the stem fracture initiated and propagated in fatigue.Post fracture abrasion was observed on the fracture surface and obscured the final fracture region.Damage consistent with contact against a hard object was observed on the superior surface near the approximate fracture origin.In-service wear consistent with contact against the acetabular insert was observed on the femoral head.Damage consistent with contact against a hard objected was observed on the articulating surface of the femoral head.Elemental analysis showed the stem is consistent with the astm f1586 alloy.Elemental analysis showed the head is consistent with the astm f1586 alloy.The head catalog number is unknown; therefore, consistency with the drawing could not be confirmed.Debris was observed on the main body of the stem.Elemental analysis showed the debris in location 1 is consistent with an oxide, the base material, and biological material.Elemental analysis showed the debris in location 2 is consistent with an oxide, the base material, biological material, and bone cement.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: a review of the provided medical records by a clinical consultant stated the following comment: x-ray and photo confirmed fractured femoral stem, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: clinician review of the provided x-ray and evaluation of the returned device confirmed the reported event.The stem fractured in the main body and the proximal portion remained in the head.The direction of fracture propagation was determined with macroscopic surface features (beach marks) on the fracture surface associated with the proximal portion of the stem.The fracture originated on the lateral surface and propagated to the medial surface.Fatigue striations were observed which indicate the stem fracture initiated and propagated in fatigue.Post fracture abrasion was observed on the fracture surface and obscured the final fracture region.Damage consistent with contact against a hard object was observed on the superior surface near the approximate fracture origin.In-service wear consistent with contact against the acetabular insert was observed on the femoral head.Damage consistent with contact against a hard objected was observed on the articulating surface of the femoral head.Elemental analysis showed the stem is consistent with the astm f1586 alloy.Elemental analysis showed the head is consistent with the astm f1586 alloy.The head catalog number is unknown; therefore, consistency with the drawing could not be confirmed.Debris was observed on the main body of the stem.Elemental analysis showed the debris in location 1 is consistent with an oxide, the base material, and biological material.Elemental analysis showed the debris in location 2 is consistent with an oxide, the base material, biological material, and bone cement.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided.Further information such as primary and revision operative reports, clinical and past medical history, and additional serial dated x-rays 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
It was reported that the patient presented with pain in left hip.Upon x-ray a fracture of stem was noticed.

• 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: 9520429
• Report Number: 0002249697-2019-04121
• Device Sequence Number: 458439
• Product Code: JDI
• UDI-Device Identifier: 04546540153234
• UDI-Public: 04546540153234
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2020

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
• Device Lot Number: G5576337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 11/28/2019
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 03/09/2020
• 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: 65 YR
• Patient Weight: 132