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

Model Number	2080-0040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
This pi is for the post-revision of the patient's acetabular shell.Rep made aware on (b)(6) 2021.Patient has not been revised as of the time of pi creation.As reported: "it was reported that a left total hip replacement had a loose acetabular component done from a prior surgery, date unknown.Upon reviewing the x-rays it was apparent the cup was loose and displaced.Dr requested a revision cup, mdm liner, insert and head.He also requested a new restoration modular body due to the pre surgery identification.The procedure was performed through a posterior approach.The old cup was removed.The new body, cup liner and head were implanted per surgical technique as well as 7 screws into the acetabulum.The patient appeared to have satisfactory stability and leg length per dr.An intra operative x-ray was taken to confirm the placement.Satisfied dr closed up the procedure.I was informed yesterday (b)(6) 2021 that the new implants have again become loose and dislodged from the acetabulum.Dr is now in the planning stages for a follow up procedure." spoke to rep, who provided the usage sheet from the revision on (b)(6) 2021.Rep confirmed there are no allegations against the revised liner, head, or restoration modular proximal body, and also confirmed that no further information will be released by the hospital or surgeon.
Additional 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.
Additional 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 or Problem Description
This pi is for the post-revision of the patient's acetabular shell.Rep made aware on (b)(6) 2021.Patient has not been revised as of the time of pi creation.As reported: "it was reported that a left total hip replacement had a loose acetabular component done from a prior surgery, date unknown.Upon reviewing the x-rays it was apparent the cup was loose and displaced.Dr requested a revision cup, mdm liner, insert and head.He also requested a new restoration modular body due to the pre surgery identification.The procedure was performed through a posterior approach.The old cup was removed.The new body, cup liner and head were implanted per surgical technique as well as 7 screws into the acetabulum.The patient appeared to have satisfactory stability and leg length per dr.An intra operative x-ray was taken to confirm the placement.Satisfied dr closed up the procedure.I was informed yesterday (b)(6) 2021 that the new implants have again become loose and dislodged from the acetabulum.Dr is now in the planning stages for a follow up procedure." spoke to rep, who provided the usage sheet from the revision on (b)(6) 2021.Rep confirmed there are no allegations against the revised liner, head, or restoration modular proximal body, and also confirmed that no further information will be released by the hospital or surgeon.

• 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
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: joann lavatelli ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12916834
• Report Number: 0002249697-2021-02005
• Device Sequence Number: 14770190
• Product Code: JDI
• UDI-Device Identifier: 07613327037135
• UDI-Public: 07613327037135
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K943549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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: 05/30/2026
• Device Model Number: 2080-0040
• Device Catalogue Number: 2080-0040
• Device Lot Number: NY34TH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Female