MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X50 SELF-TAP; PROSTHESIS, HIP

Catalog Number	00625006550
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a right hip revision approximately one-year post implantation due to loosening and an infection.During the procedure it was noted that some of the screws were broken, some of them pulled through the cup and others had pulled out of the cup.The cup and screws were removed and replaced.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00007, 0001822565-2023-00008, 0001822565-2023-00010, 0001822565-2023-00011 and 0001822565-2023-00012.00625006525/j7109046/ bone scr 6.5x25 self-tap, 110010273/6416662/ g7 osseoti multihole 70mm i, 00625006525/j7126860/ bone scr 6.5x25 self-tap, 00625006540/j7119546/ bone scr 6.5x40 self-tap, 00625006520/64735195/ bone scr 6.5x20 self-tap, 11-301302/arcos con sz b std 60mm, 11-300917/arcos 17x190mm splt tpr dist and 00-2232-004-18/cerclage cocr 1.8mmx635xx.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided picture identified the explanted shell and some screws covered in bio-debris.Some of the screw are shown sticking out of the shell holes.One of the screws appears fractures.The provided video shows the surgeon forcing the screw in from the outer spherical surface shell hole, with other screws sticking out of the other holes.No further evaluations can be made from the provide pictures or video.Dhr was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined for the shell loosening and screws breaking/pulling out of the cup.No problem was found with the implants in relation to the infection.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BONE SCR 6.5X50 SELF-TAP
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16112725
• Report Number: 0001822565-2023-00009
• Device Sequence Number: 6811793
• Product Code: LPH
• UDI-Device Identifier: 00889024119857
• UDI-Public: (01)00889024119857(17)310207(10)J6965914
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00625006550
• Device Lot Number: J6965914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 01/06/2023
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 127 KG