MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH EXETER V40 STEM 44MM NO 1; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	0580-1-441
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Codes	Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	11/29/2018
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.Pending investigation completion.
Event or Problem Description
Stryker rep reported that patient underwent revision surgery on an exeter stem.Revision date (b)(6) 2018.
Additional Manufacturer Narrative
An event regarding revision involving a exeter stem was reported.Material analysis of the returned device confirmed crack/fracture of the stem.Method & results product evaluation and results: visual inspection was performed on the returned device as part of mar dated (b)(6) 2019 which noted the following: damages were observed on the stem, consistent with the explantation process in addition to the cement mantle breakdown.The fracture surfaces associated with the distal and proximal ends of the stem.Based on macroscopic features, the approximate direction of fracture propagation.The fracture propagated from the lateral surface to the medial surface of the stem.Material analysis of the returned device noted the following: the stem fractured at the neck in a fatigue manner.Damages were observed on the stem, consistent with the explantation process in addition to the cement mantle breakdown process.Eds showed the stem was consistent with astm f1586 alloy.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 information by a clinical consultant indicated: rejected for medical review: provided x-ray for the left hip showed dissociated stem with trunnion deformity.Need primary/revision operative reports, office/clinical reports, serial x-rays, and examination of the 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: medical review of the provided x-rays concluded the following: provided x-ray for the left hip showed dissociated stem with trunnion deformity.Need primary/revision operative reports, office/clinical reports, serial x-rays, and examination of the explanted components.Explanted components were retrieved and material analysis concluded the following: the stem fractured at the neck in a fatigue manner.Damages were observed on the stem, consistent with the explantation process in addition to the cement mantle breakdown process.Eds showed the stem was consistent with astm f1586 alloy.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Crack/fracture of the stem was therefore confirmed however, the exact cause of the event could not be determined because insufficient information was provided.Further information such primary/revision operative reports, office/clinical reports, serial 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
Stryker rep reported that patient underwent revision surgery on an exeter stem.Revision date (b)(6) 2018.

• Brand Name: EXETER V40 STEM 44MM NO 1
• 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: 8198027
• Report Number: 0002249697-2018-04127
• Device Sequence Number: 295495
• Product Code: JDI
• UDI-Device Identifier: 04546540153302
• UDI-Public: 04546540153302
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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: 07/31/2014
• Device Catalogue Number: 0580-1-441
• Device Lot Number: G2907067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 03/28/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 124