MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH RESTORATION GAP II ACET SHELL; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Catalog Number 2082-0056R

Device Problems Break (1069); Fracture (1260); Loss of Osseointegration (2408)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Pain (1994); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Insufficient Information (4580)

Event Date 03/24/2023

Event Type  Injury  

Event Description

This pi for revision : son of patient stated his mother had primary right hip surgery on (b)(6) 2022.On (b)(6) 2022 patient experienced increase pain and x-rays confirmed a 1/2 inch wide break.It was also stated that on (b)(6) 2022 a "cage was added" due to her implant "popping out" twice.Son did not confirm what was popping out.A revision was then performed on (b)(6) 2023; "head and cup" were replaced with competitor products.

Manufacturer Narrative

Reported event: an event regarding crack/fracture involving an unknown 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: no medical records were received for review with a clinical consultant.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: it was reported that the patient's hip was revised following a reported "break." the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays 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.H3 other text : device not returned.

Event Description

This pi for revision.Son of patient stated his mother had primary right hip surgery on (b)(6) 2022.On (b)(6) 2022 patient experienced increase pain and x-rays confirmed a 1/2 inch wide break.It was also stated that on (b)(6) 2022 a "cage was added" due to her implant "popping out" twice.Son did not confirm what was popping out.A revision was then performed on (b)(6) 2023; "head and cup" were replaced with competitor products.Update: on (b)(6) 2023 the patient was revised due to aseptic loosening of the acetabular component and acetabular bone loss resulting in pelvic discontinuity whereby all components were explanted and a custom tri-flange competitor construct was implanted.

Manufacturer Narrative

An event regarding loosening, periprosthetic fracture and crack/fracture involving a restoration shell was reported.The loosening and periprosthetic fracture events were confirmed via clinician review of the provided medical records.Crack/fracture 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 information by a clinical consultant indicated: "conclusion/assessment: there was a revision surgery performed for acetabular loosening and bone loss with a pelvic discontinuity.The reconstruction was performed with a gap cup and the stem retained.There were subsequent dislocations and eventual failure of the reconstruction cage with dislocation and metallic implant fracture (by description).The hip was re-revised to a triflange construct and new modular stem.No radiographs were provided for review.Event confirmation: failure of a gap cup reconstruction can be confirmed.Root cause: the root cause was trauma combined instability and pelvic discontinuity." 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 has been 1 other similar event for the lot referenced which relates to loosening and periprosthetic fracture for the same device/patient; therefore, no further trending is required for this commonality.Conclusions: it was reported that the patient was revised due to aseptic acetabular loosening, pelvic discontinuity, and device fracture.A review of the provided medical information by a clinical consultant indicated: "conclusion/assessment: there was a revision surgery performed for acetabular loosening and bone loss with a pelvic discontinuity.The reconstruction was performed with a gap cup and the stem retained.There were subsequent dislocations and eventual failure of the reconstruction cage with dislocation and metallic implant fracture (by description).The hip was re-revised to a triflange construct and new modular stem.No radiographs were provided for review.Event confirmation: failure of a gap cup reconstruction can be confirmed.Root cause: the root cause was trauma combined instability and pelvic discontinuity." 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.

• Brand Name: RESTORATION GAP II ACET SHELL
• 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-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann ripoli ; 325 corporate drive; centennial park, elstree; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17008993
• MDR Text Key: 315999342
• Report Number: 0002249697-2023-00585
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 07613327017571
• UDI-Public: 07613327017571
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/04/2023

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: 2082-0056R
• Device Lot Number: 00054579A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/26/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2020
• 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: 90 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Race: White