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 Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	12/13/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: ¿revision surgery required for an exeter stem implanted about ten years ago which broke at the level of the head.The patient said he heard a cracking sound and then he fell down.".
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.Device not returned.
Event or Problem Description
The following was reported: ¿revision surgery required for an exeter stem implanted about ten years ago which broke at the level of the head.The patient said he heard a cracking sound and then he fell down.".
Additional Manufacturer Narrative
Reported event: an event regarding crack/fracture involving an exeter stem was reported.The event was confirmed via evaluation of the returned device.Method & results: -product evaluation and results: visual inspection: visual inspection was performed as part of the material analysis which indicated the following: exeter v40 stem with fracture location.On visual examination, the fracture was observed through the neck of the stem with the femoral head remaining locked on the stem trunnion.Surface material damage is observed on the mid-stem region of the medial and lateral sides of the stem, respectively.These indications were likely a result of third-body damage and micromotion effects due to cement mantle breakdown.Material analysis: a material analysis was performed and indicated the following: "stereo microscope imaging was performed on both the proximal and distal fracture surfaces.Based on macroscopic surface features observed, including beach marks, the approximate direction of propagation p was determined.The final fracture f location is also labelled.Due to extensive mechanical damage observed on both fracture surfaces, the precise location of the fracture origin could not be identified.The macroscopic surface features observed on the fracture surface indicate the component fractured due to fatigue.The surface near the neck of the stem shows explantation damage.Stereo microscope imaging was also performed on the insert.Damage consistent with delamination and material loss was observed around the circumference of the insert, most likely a result of contact with the neck of the stem.Yellow discoloration consistent with absorption of synovial fluid was also observed.Review of exeter v40 stem 44 mm, catalogue # 0580-1-441 confirmed a fracture through the neck of the stem.Characterisation using stereo microscopy and scanning electron microscopy confirmed the component fracture propagated due to fatigue with the final fracture in overload.-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 patient was revised due to a fractured exeter stem.A material analysis was performed on the returned device and indicated the following: "stereo microscope imaging was performed on both the proximal and distal fracture surfaces.Based on macroscopic surface features observed, including beach marks, the approximate direction of propagation p was determined.The final fracture f location is also labelled.Due to extensive mechanical damage observed on both fracture surfaces, the precise location of the fracture origin could not be identified.The macroscopic surface features observed on the fracture surface indicate the component fractured due to fatigue.The surface near the neck of the stem shows explantation damage.Stereo microscope imaging was also performed on the insert.Damage consistent with delamination and material loss was observed around the circumference of the insert, most likely a result of contact with the neck of the stem.Yellow discoloration consistent with absorption of synovial fluid was also observed.Review of exeter v40 stem 44 mm, catalogue # 0580-1-441 confirmed a fracture through the neck of the stem.Characterisation using stereo microscopy and scanning electron microscopy confirmed the component fracture propagated due to fatigue with the final fracture in overload." 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.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 13236889
• Report Number: 0002249697-2022-00069
• Device Sequence Number: 14523055
• Product Code: JDI
• UDI-Device Identifier: 04546540153234
• UDI-Public: 04546540153234
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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: G7434620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 82 YR
• Patient Sex: Unknown