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

Model Number	0580-1-351
Medical Device Problem Codes	Loss of Osseointegration (2408); Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Inadequate Osseointegration (2646)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
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.An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
Event or Problem Description
It was reported that the patient's left hip was revised due to pain, stiffness, resorption and loosening.Surgeon suspects the cause as: "i think her body is reacting to and rejecting the bone cement.An allergy has to be considered." cement was removed and the stem and head revised.There are no allegations against the revised head.
Event or Problem Description
It was reported that the patient's left hip was revised due to pain, stiffness, resorption and loosening.Surgeon suspects the cause as: "i think her body is reacting to and rejecting the bone cement.An allergy has to be considered." cement was removed and the stem and head revised.There are no allegations against the revised head.
Additional Manufacturer Narrative
An event regarding loosening involving an exeter stem was reported.The event was confirmed via clinician review of the provided medical records.Method & results: -device evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical records by a clinical consultant indicated: a patient had increasing pain and disfunction approximately 3 years after a cemented hybrid tha with an exeter stem and trident psl cup.An mri showed bone resorption and loosening of the stem.A revision surgery was proposed.More subtle but similar finding were noted on the right.A revision was felt to be likely on the right as well.The surgeon hypothesized that the patient may be reacting to the cement, per perhaps have an allergy.Event confirmation: a left hip revision surgery event cannot be confirmed.Bone loss and likely loosening around a 3 year old left hip exeter stem can be confirmed.Allergy or adverse reaction to bone cement cannot be confirmed.Mri changes only can be confirmed on the right side.Root cause: a root cause cannot be ascertained from the records provided for review.-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.Conclusion: a review of the provided medical records by a clinical consultant indicated: : a patient had increasing pain and disfunction approximately 3 years after a cemented hybrid tha with an exeter stem and trident psl cup.An mri showed bone resorption and loosening of the stem.A revision surgery was proposed.More subtle but similar finding were noted on the right.A revision was felt to be likely on the right as well.The surgeon hypothesized that the patient may be reacting to the cement per perhaps have an allergy.Event confirmation: a left hip revision surgery event cannot be confirmed.Bone loss and likely loosening around a 3 year old left hip exeter stem can be confirmed.Allergy or adverse reaction to bone cement cannot be confirmed.Mri changes only can be confirmed on the right side.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 35.5MM
• 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: joann ripoli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16433968
• Report Number: 0002249697-2023-00185
• Device Sequence Number: 15285260
• Product Code: LPH
• UDI-Device Identifier: 04546540153234
• UDI-Public: 04546540153234
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K121308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 04/25/2023

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: 09/30/2024
• Device Model Number: 0580-1-351
• Device Catalogue Number: 0580-1-351
• Device Lot Number: G7720564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 02/24/2023
• Supplement Report FDA Received Date: 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2019
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 68 KG