MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN ABG2 6 G/L MONOLITHIC STEM; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU

Catalog Number UNK_SHC

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Dislocation (2374)

Event Date 08/31/2023

Event Type  Injury  

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.H3 other text : device not returned to the manufacturer.

Event Description

Implant in patient keeps dislocating, patient bought into hospital for revision surgery.The stem was revised due to constrained liner not sitting well with previous stem, so surgeon decided to revise the stem also.

Manufacturer Narrative

An event regarding revision involving an unknown stem was reported.The event was not confirmed.Method & results: -product evaluation and results: the device was not returned for evaluation; however, photographs were provided for review.The photographs show a recently explanted stem with some visible implantation/explanation scratches.-clinician review: a review of the provided medical records by a clinical consultant indicated: "the x-ray demonstrates a press fit tha in expected position.It appears well fixed.The photographs of the explanted stem , cup and head show evidence of bone attached the components showing they had ingrown."[.]".Explantation of a press fit tha is confirmed.No information regarding causation for the revision was provided.Should additional information become available i would be happy to further this assessment." -product history review: not performed as the device lot number is invalid.-complaint history review: not performed as the device lot number is invalid.Conclusions: it was reported that the patient was revised due to dislocation.A review of the provided medical records by a clinical consultant indicated: "the x-ray demonstrates a press fit tha in expected position.It appears well fixed.The photographs of the explanted stem , cup and head show evidence of bone attached the components showing they had ingrown."[.]".Explantation of a press fit tha is confirmed.No information regarding causation for the revision was provided.Should additional information become available i would be happy to further this assessment." further information such as return of the device, pathology reports, pre- and post-operative and the revision 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

Implant in patient keeps dislocating, patient bought into hospital for revision surgery.The stem was revised due to constrained liner not sitting well with previous stem, so surgeon decided to revise the stem also.

• Brand Name: UNKNOWN ABG2 6 G/L MONOLITHIC STEM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, NON-POROUS, CALICU
• 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: arunabha mukherjee ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17807119
• MDR Text Key: 324128598
• Report Number: 0002249697-2023-01077
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• 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
• Date Manufacturer Received: 01/30/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 126 KG