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

Catalog Number	0580-1-351
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Codes	Unspecified Infection (1930); Injury (2348); Inadequate Osseointegration (2646)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reported event: an event regarding infection involving a exeter stem was reported.Infection could not be confirmed.However, the medical review identified loosening of the exeter stem.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remained implanted medical records received and evaluation: a review of the provided medical information by a clinical consultant indicated: provided x-ray confirms loose cemented stem.Need 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.There have been no other similar events for the sterile lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as operative reports, office/clinical reports, serial x-rays, and examination of the explanted components are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
Event or Problem Description
As reported: "procedure: i&d and head and [competitor] liner exchange.Pre-op diagnosis: septic vs.Aseptic loosening status post complex primary right total hip.No further information available per hospital".A 32 -4 biolox head was revised to a 32 biolox head with -2.5 sleeve.Spoke to rep.Patient was revised due to infection.Rep provided pre-revision x-rays and a usage sheet from the prior procedure and confirmed that no further information will be released by the hospital or surgeon.Update 08 october, 2019: review of the x-ray by a clinician confirms loose cemented stem.

• 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: 9281832
• Report Number: 0002249697-2019-03690
• Device Sequence Number: 2483972
• Product Code: JDI
• UDI-Device Identifier: 04546540153234
• UDI-Public: 04546540153234
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K173499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2019

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: 11/30/2023
• Device Catalogue Number: 0580-1-351
• Device Lot Number: G7528341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/05/2019
• 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: 59 YR
• Patient Weight: 39