MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH GAP PLATE SCREWS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number	2080-0045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The following devices were also listed in this report: gap plate screws, cat# 2080-0035, lot# xt1wx9; gap plate screws, cat# 2080-0030, lot# ex5lhl.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.A 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 available.
Event or Problem Description
A 60mm tritanium cup required revision for loosening.The surgeon believed it was not the fault of the prosthesis.2nd revision of original competitor cup.Update: "the screws were accidentally discarded at least one was broken as well.".
Event or Problem Description
A 60mm tritanium cup required revision for loosening.The surgeon believed it was not the fault of the prosthesis.2nd revision of original competitor cup update: "the screws were accidentally discarded at least one was broken as well.".
Additional Manufacturer Narrative
An event regarding crack/fracture involving a screw was reported.The event was confirmed by medical review.It is important to note that three screws were reported for this event, and none were returned for analysis.As a result, it was not possible to confirm which screw was fractured.Method & results: -device evaluation and results: not performed as product was not returned.-clinician review: a review of the provided medical records and x-rays by a clinical consultant indicated: x-rays confirms loose cup and a broken screw, need additional information; primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components.-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 exact cause of the event could not be determined because insufficient information was provided.Additional information including primary and revision operative reports, clinical and past medical history, additional serial dated x-rays and examination of explanted components are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.No further investigation for this event is possible at this time as no devices and/ or insufficient information was received by stryker orthopaedics.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: GAP PLATE SCREWS
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8910730
• Report Number: 0002249697-2019-02911
• Device Sequence Number: 16520086
• Product Code: JDI
• UDI-Device Identifier: 07613327037173
• UDI-Public: 07613327037173
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K943549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2019

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: 10/31/2018
• Device Catalogue Number: 2080-0045
• Device Lot Number: MMPYRE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 10/16/2019
• 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: 76 YR
• Patient Weight: 80