MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X40 SELF-TAP; PROSTHESIS, HIP

Catalog Number 00625006540

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00007, 0001822565-2023-00008, 0001822565-2023-00009, 0001822565-2023-00010, 0001822565-2023-00012.00625006525/j7109046/ bone scr 6.5x25 self-tap, 110010273/6416662/ g7 osseoti multihole 70mm i, 00625006550/j6965914/ bone scr 6.5x50 self-tap, 00625006525/j7126860/ bone scr 6.5x25 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, 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 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.

Event Description

No additional event information to report at this time.

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 6.5X40 SELF-TAP
• Type of Device: 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: 16112733
• MDR Text Key: 306805171
• Report Number: 0001822565-2023-00011
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 00889024119840
• UDI-Public: (01)00889024119840(17)311009(10)J7119546
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 00625006540
• Device Lot Number: J7119546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2022
• Initial Date FDA Received: 01/06/2023
• Supplement Dates Manufacturer Received: 02/06/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: SEE H10.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 127 KG