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

Model Number	2082-0052L
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Injury (2348); Hip Fracture (2349)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not returned.
Event or Problem Description
It was reported that the patient's left hip was revised due to multiple acetabular failures.Surgeon reported existing factor of severe osteoporosis.A stryker restoration gap cage was revised.
Additional Manufacturer Narrative
Reported event: an event regarding patient factors (failure of a periprosthetic fracture to heal post original revision surgery) involving a restoration shell was reported.The event was confirmed through clinician review of the provided medical records.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: the available medical records were provided for a review to the consulting clinician which concluded, " review of these records confirm multiple revision that were performed for a periprosthetic acetabular fracture.No records were available that would indicate the cause of the fracture.Nor were any records available to document an ill fitting custom triflange acetabular component.-device history review: all 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 reported lot.Conclusion: the available medical records were provided for a review to the consulting clinician which concluded that review of these records confirm multiple revision were performed due to failure of a periprosthetic fracture to heal post original revision surgery.No records were available that would indicate the cause of the fracture.Nor were any records available to document an ill fitting custom triflange acetabular component.The exact cause of the event could not be determined because insufficient information was provided.¿ additional information including device details, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not returned.
Event or Problem Description
It was reported that the patient's left hip was revised due to multiple acetabular failures.Surgeon reported existing factor of severe osteoporosis.A stryker restoration gap cage was revised.

• Brand Name: RESTORATION GAP II ACET SHELL
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10457073
• Report Number: 0002249697-2020-01735
• Device Sequence Number: 17137540
• Product Code: LZO
• UDI-Device Identifier: 07613327017540
• UDI-Public: 07613327017540
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K980774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2021

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: 04/30/2021
• Device Model Number: 2082-0052L
• Device Catalogue Number: 2082-0052L
• Device Lot Number: 00033298A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 01/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR