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

Catalog Number	0580-1-352
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	08/26/2019
Type of Reportable Event	Serious Injury
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.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
The patient underwent a primary hip surgery on (b)(6) 2017.After performing a normal recovery, on (b)(6) he went to the doctor because he had pain.The doctor when checking and after seeing the plaque, confirms that the prosthesis placed is broken.After a telephone communication with dr, he says that the patient suffered a fall, it is not known if this is the root cause.The surgeon of the second consultation is not the same surgeon of the primary surgery.
Additional Manufacturer Narrative
An event regarding crack/fracture involving an exeter stem was reported.The event was confirmed by inspection of the returned device and the clinician review.Method & results: device evaluation and results: visual inspection was performed for the returned device which indicated that the devices were examined with the aid of a stereo microscope at magnifications up to 50x.Damage was observed on the stem consistent with the implantation/explantation process on the neck and main body.Debris was observed on the anterior surface of the main body and was further analyzed using a scanning electron microscope (sem).Damage consistent with the implantation/explantation process was observed on the anterior and posterior surfaces of the main body.The distal fracture surface exhibited beach marks which are indicative of fatigue fracture.Post fracture abrasion was also observed on the post fracture abrasion.The proximal fracture surface exhibited beach marks, which are indicative of fatigue fracture; post fracture abrasion was also observed.The fatigue striations suggest the crack originated on the lateral surface and propagates in the medial direction.A scratch was observed on both the proximal and distal fracture pieces on the superior surface of the stem near the fracture origin, consistent with contact against a hard object.The proximal fracture surface was further analyzed with a sem.A material analysis was performed.The report concluded that the hip stem fractured in fatigue and the final fracture occurred in overload.Scratching was observed near the approximate location of fracture origin, consistent with contact against a hard object.Damage consistent with the implantation/explantation process was observed on the anterior and posterior surface of the stem main body.Debris was observed on the main body of the stem; eds showed it was consistent with an oxide, biological material, and the base material.Xrf showed the stem base alloy was consistent with an astm f1586 alloy, which is consistent with the drawing.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.Clinician review: the available medical records were provided to a consulting clinician for a review which was rejected stating - "x-ray provided confirms broken component, need additional information; primary and revision operative reports (not handwritten), clinical and past medical history and examination of explanted components." device history review: review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient had pain.The patient's doctor reported the prosthesis was broken after the patient had a fall.The available medical records were provided to a consulting clinician for a review which was rejected stating that the x-ray provided confirms broken component, need additional information; primary and revision operative reports (not handwritten), clinical and past medical history and examination of explanted components.A material analysis was conducted for the returned device.The report concluded that the hip stem fractured in fatigue and the final fracture occurred in overload.Scratching was observed near the approximate location of fracture origin, consistent with contact against a hard object.Damage consistent with the implantation/explantation process was observed on the anterior and posterior surface of the stem main body.Debris was observed on the main body of the stem; eds showed it was consistent with an oxide, biological material, and the base material.Xrf showed the stem base alloy was consistent with an astm f1586 alloy, which is consistent with the drawing.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.No further investigation is possible at this time.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
The patient underwent a primary hip surgery on (b)(6) 2017.After performing a normal recovery, on (b)(6) he went to the doctor because he had pain.The doctor when checking and after seeing the plaque, confirms that the prosthesis placed is broken.After a telephone communication with dr, he says that the patient suffered a fall, it is not known if this is the root cause.The surgeon of the second consultation is not the same surgeon of the primary surgery.

• 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
• MDR Report Key: 9128931
• Report Number: 0002249697-2019-03336
• Device Sequence Number: 19465131
• Product Code: JDI
• UDI-Device Identifier: 04546540153241
• UDI-Public: 04546540153241
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

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: 07/31/2022
• Device Catalogue Number: 0580-1-352
• Device Lot Number: G7120685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 12/06/2019
• 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: Other
• Patient Age: 79 YR
• Patient Weight: 88