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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Metal Related Pathology (4530)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, "the surgeon advised that he was revising an exeter/mitch combination due to elevated cobalt/chromium levels in the patient.".
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.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: mmh-9988-0448; mitch trh md hd sz 48-4; lot # fm071593 mac-9988-4854; std mitch trh cp sz 48/54 ; lot # fm59498011.
Event or Problem Description
It was reported, "the surgeon advised that he was revising an exeter/mitch combination due to elevated cobalt/chromium levels in the patient.".
Additional Manufacturer Narrative
Reported event: an event regarding corrosion and abnormal ion level involving an exeter stem was reported.The corrosion event was confirmed via evaluation of the returned device.Abnormal ion level was not confirmed.Method & results: -product evaluation and results: visual inspection was performed as part of mar that indicated "[.]the exeter v40 stem.On visual examination, areas of discoloration were observed around the stem trunnion.Stereo microscope shows material loss and wear around the stem trunnion, consistent with in-vivo wear.Explantation damage was also observed.An area of the mid-stem region, with surface material damage observed.Surface material damage was also observed on the lateral and distal surfaces of the stem.These indications were likely a result of third-body damage and micromotion effects due to cement mantle breakdown." [.] material analysis: mar report indicated "[.] material wear was observed around the stem 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 discolouration, 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: a review of the device history records could not be performed as lot code information was unknown.-complaint history review: a complaint history review could not be performed as lot code information was unknown.Conclusions: it was reported that the patient was revised due to elevated cobalt/chromium levels.Visual inspection was performed as part of mar that indicated "[.] the exeter v40 stem.On visual examination, areas of discoloration were observed around the stem trunnion.Stereo microscope shows material loss and wear around the stem trunnion, consistent with in-vivo wear.Explantation damage was also observed.An area of the mid-stem region, with surface material damage observed.Surface material damage was also observed on the lateral and distal surfaces of the stem.These indications were likely a result of third-body damage and micromotion effects due to cement mantle breakdown." [.] material analysis: mar report indicated "[.] material wear was observed around the stem 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 discolouration, indicating corrosion.No manufacturing related defects were observed on the device surfaces examined."[.]no further investigation for this event is possible at this time.If additional information become available to indicate further evaluation is warranted, this record will be reopened.

• 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: 16241035
• Report Number: 0002249697-2023-00069
• Device Sequence Number: 17780308
• 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: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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 Model Number: 0580-1-441
• Device Catalogue Number: 0580-1-441
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2023
• Supplement Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male