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

Model Number	0580-1-441
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	11/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision took place: revision of an exeter/mitch combination due to elevated cobalt/chromium levels in the patient.
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.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.The mitch trh acetabular system components are oem devices.Stryker orthopaedics is not the legal manufacturer of the mitch devices.However, since this device was used in conjunction with a stryker device they are being listed as associated devices: std mitch trh cp sz 50/56, cat #: mac-9988-5056, lot #: fm059145; mitch trh md hd sz 50-4, cat #: mmh-9988-0450, lot #: fm067775.
Additional Manufacturer Narrative
Reported event: an event regarding wear, corrosion, and abnormal ion level involving an exeter stem was reported.Wear and corrosion were confirmed via evaluation of the returned device.Abnormal ion level was not confirmed.Method & results: product evaluation and results: visual inspection: visual inspection of the returned device was performed as part of the material analysis: "on visual examination, material loss and areas of discoloration were observed around the intersection of the neck and trunnion of the stem." material analysis: a material analysis was performed which concluded the following: "review of the exeter v40 stem, catalogue # 0580-1-441, lot code g1660672 was completed using visual examination, stereo microscopy examination and energy dispersive spectroscopy examination.Material loss was observed at the intersection between the neck of the stem and the trunnion, consistent with in-vivo wear, potentially related to the stem trunnion losing taper lock with the head taper.Elemental analysis confirmed the presence of oxygen in the areas with material loss, indicating corrosion.No manufacturing related defects were observed on the device 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 devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to elevated metal ion levels.A material analysis was performed on the returned device and it concluded the following: "review of the exeter v40 stem, catalogue # 0580-1-441, lot code g1660672 was completed using visual examination, stereo microscopy examination and energy dispersive spectroscopy examination.Material loss was observed at the intersection between the neck of the stem and the trunnion, consistent with in-vivo wear, potentially related to the stem trunnion losing taper lock with the head taper.Elemental analysis confirmed the presence of oxygen in the areas with material loss, indicating corrosion.No manufacturing related defects were observed on the device surfaces examined." the elevated metal ion levels could not be confirmed as no medical records were provided for review.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
It was reported that a revision took place: revision of an exeter/mitch combination due to elevated cobalt/chromium levels in the patient.

• Brand Name: EXETER V40 STEM 44MM NO 1
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• 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: marisol santiago ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15975819
• Report Number: 0002249697-2022-01823
• Device Sequence Number: 6922699
• Product Code: LPH
• UDI-Device Identifier: 04546540153302
• UDI-Public: 04546540153302
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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: 12/31/2011
• Device Model Number: 0580-1-441
• Device Catalogue Number: 0580-1-441
• Device Lot Number: G1660672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 12/14/2022
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2006
• 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: 78 YR
• Patient Sex: Male