MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH SIMPLEX P WITH TOBRAMYCIN 1 PACK; BONE CEMENT, ANTIBIOTIC

Model Number 6197-9-001

Device Problems Loss of Osseointegration (2408); Patient Device Interaction Problem (4001)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Inadequate Osseointegration (2646); Reaction to Medicinal Component of Device (4574)

Event Date 01/30/2023

Event Type  Injury  

Event 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.

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 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.

Manufacturer Narrative

Reported event: an event regarding loosening and allergy/reaction involving simplex cement mix was reported.The event of loosening was confirmed via clinician review of the provided medical records.Allergy/reaction was not confirmed.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 or 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: a review of the batch manufacturing records indicates the 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 or 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: SIMPLEX P WITH TOBRAMYCIN 1 PACK
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA ; EI NA
• Manufacturer Contact: anna ryan ; raheen business park; limerick, NJ NA ; EI NA ; 2018315000
• MDR Report Key: 16431494
• MDR Text Key: 310129812
• Report Number: 0002249697-2023-00184
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 07613327128420
• UDI-Public: 07613327128420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K014199
• 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: 04/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 6197-9-001
• Device Catalogue Number: 6197-9-001
• Device Lot Number: MFA052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 68 KG