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

Model Number	0580-1-441
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Codes	Granuloma (1876); Inadequate Osseointegration (2646)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation shall be performed to try to identify the root cause of the event.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
Tha revision was performed due to the cup loosening.During the revision a necrotic tissue-like granulation tissue filling around the trunnion of the stem was found, and when the head was removed, the entire trunnion lost its luster and rust-like substance was adhered.Please investigate the state the trunnion.
Additional Manufacturer Narrative
Reported event: an event regarding fretting and corrosion involving an exeter stem was reported.The event was confirmed via evaluation of the returned device.Method & results: product evaluation and results: a material analysis has been performed.The report concluded that plastic surface deformation consistent with micro-motion at the stem-cement interface was observed.Damage consistent with the explantation process was also observed on the stem.Damage consistent with interaction between the head taper and stem trunnion was also observed.Eds showed that the stem and head chemistries were consistent with astm f1586 alloys, which is consistent the drawings.The observed debris on both the head and stem was consistent with an oxide, corrosion product, and biological material.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: review of the device history records indicate (b)(4) were manufactured and accepted into final stock on 09-oct-2007 with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: evaluation of the returned device indicated that damage consistent with interaction between the head taper and stem trunnion was also observed.Eds showed that the stem and head chemistries were consistent with astm f1586 alloys, which is consistent the drawings.The observed debris on both the head and stem was consistent with an oxide, corrosion product, and biological material.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 pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes 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
Tha revision was performed due to the cup loosening.During the revision a necrotic tissue-like granulation tissue filling around the trunnion of the stem was found, and when the head was removed, the entire trunnion lost its luster and rust-like substance was adhered.Please investigate the state the trunnion.

• 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: 10823920
• Report Number: 0002249697-2020-02420
• Device Sequence Number: 3204534
• Product Code: JDI
• UDI-Device Identifier: 04546540153302
• UDI-Public: 04546540153302
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: 10/31/2012
• Device Model Number: 0580-1-441
• Device Catalogue Number: 0580-1-441
• Device Lot Number: G2026830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 03/02/2021
• 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: 87 YR
• Patient Weight: 68