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

Catalog Number UNK_SHC

Device Problems Loss of Osseointegration (2408); Insufficient Information (3190)

Patient Problems Pain (1994); Inadequate Osseointegration (2646); Reaction to Medicinal Component of Device (4574)

Event Date 01/30/2023

Event Type  Injury  

Event Description

This pi is for the patient's right hip.In providing information for revision of the patient's left hip for pain, stiffness, resorption and loosening (surgeon suspects this is due to patient reaction/ rejection to cement), office visit note states "the mri and her plain images demonstrate that she is developing a similar disease process involving her right hip but not as severe." surgeon reported he plans to revise the patient's right hip (date not reported).Rep confirmed an exeter stem is in situ, and that no additional information will be released by the hospital or surgeon until that hip is revised.

Manufacturer Narrative

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.

Manufacturer Narrative

An event regarding loosening involving an unknown exeter stem (right hip) was reported.The event was not confirmed.Method & results -product 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 pr 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: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: 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 pr 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.Further information such as device identification details, return of the device, 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 devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

Event Description

This pi is for the patient's right hip.In providing information for revision of the patient's left hip for pain, stiffness, resorption and loosening (surgeon suspects this is due to patient reaction/ rejection to cement), office visit note states "the mri and her plain images demonstrate that she is developing a similar disease process involving her right hip but not as severe." surgeon reported he plans to revise the patient's right hip (date not reported).Rep confirmed an exeter stem is in situ, and that no additional information will be released by the hospital or surgeon until that hip is revised.

• Brand Name: UNKNOWN EXETER STEM
• Type of Device: 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: 16441476
• MDR Text Key: 310228901
• Report Number: 0002249697-2023-00190
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SHC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 68 KG