MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCR 6.5X60 SELF-TAP; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient underwent initial hip arthroplasty.Subsequently, the patient underwent revision approximately 18 months post implantation due to implant loosening.Additional information on the reported event is unavailable.
Additional Manufacturer Narrative
(b)(4).Concomitant products: 00625006530 64631093 bone scr 6.5x30 self-tap; 00625006560 77002956 bone scr 6.5x60 self-tap; 00625006530 64609715 bone scr 6.5x30 self-tap; 00625006525 64628403 bone scr 6.5x25 self-tap; 00625006525 64574202 bone scr 6.5x25 self-tap; 00625006520 63024369 bone scr 6.5x20 self-tap; 00625006560 j6610267 bone scr 6.5x60 self-tap; 11-363664 156930 36mm cocr mod hd +6mm; 010000985 6588444 g7 freedom const e1 lnr 36mm g ;11-107018 935400 freedom constr hd 36mm t1 std; 110010267 6725624 g7 osseoti multihole 58mm g; 00236901435 3.5 mm locking screw 14 mm length; 00236902035 3.5 mm locking screw 20 mm length; 00236903035 3.5 mm locking screw 30 mm length; 00236020527 drill standard 2.7 mm diameter; customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the device was not returned by the hospital.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0002648920 - 2022 - 00013; 0001822565 - 2022 - 00137; 0002648920 - 2022 - 00014; 0002648920 - 2022 - 00015 ; 0002648920 - 2022 - 00016; 0002648920 - 2022 - 00017.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.The deice history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BONE SCR 6.5X60 SELF-TAP
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13333943
• Report Number: 0001822565-2022-00138
• Device Sequence Number: 20089303
• Product Code: LPH
• UDI-Device Identifier: 00889024119864
• UDI-Public: (01)00889024119864(17)290815(10)J6610267
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K140669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 03/31/2022

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 Model Number: N/A
• Device Catalogue Number: 00625006560
• Device Lot Number: J6610267
• 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: 01/18/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2019
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female