MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH; PROTHESIS, HIPS

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360); Unequal Limb Length (4534)
Date of Event	09/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).D10: 00625006535 bone screw self-tapping 6.5 mm dia.35 mm length j7487170.00625006540 bone screw self-tapping 6.5 mm dia.40 mm length j7548920.00625006540 bone screw self-tapping 6.5 mm dia.40 mm length j7332696.00625006530 bone screw self-tapping 6.5 mm dia.30 mm length j7526172.00625006535 bone screw self-tapping 6.5 mm dia.35 mm length j7532624.00625006540 bone screw self-tapping 6.5 mm dia.40 mm length j7353484.110024467 g7 dual mobility liner 54mm i 879840.Ep-200160 act artic e1 hip brg 28x54mm 242220.00-8777-028-01 biolx opt hd/adpt 12/14 28x-3 3137218.110010273 g7 osseoti multihole 70mm i 6307341.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 03361, 0001822565 - 2023 - 03362, 0001822565 - 2023 - 03363, 0001822565 - 2023 - 03367, 0001822565 - 2023 - 03368, 0001822565 - 2023 - 03370.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported a patient had a revision of a right hip prosthesis.Subsequently, approximately two weeks later, radiographic imaging displayed dissociation of the cup from the pelvis and ¿huge¿ pelvic defects.Upon follow-up, the patient reports having severe pain and assessment indicated that the right leg was shortened.A pmi product is currently being planned for the patient¿s next revision.
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 and/or corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial right tha was performed on an unknown date with unknown products.A revision occurred where zb products were placed.Follow ups show the cup migrated from the pelvis and there are huge bone defects.Leg shortening was also reported, however it is unknown whether that was a pre-existing condition or a result of the current issues.A revision has not yet occurred.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: marked malposition and presumed migration of the right hip arthroplasty acetabular implant as noted.A definitive root cause cannot be determined.This complaint was confirmed based on the provided medical records.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.

• Brand Name: BONE SCREW SELF-TAPPING 6.5 MM DIA. 40 MM LENGTH
• Common Device Name: PROTHESIS, HIPS
• 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: 18231783
• Report Number: 0001822565-2023-03369
• Device Sequence Number: 3227576
• Product Code: LPH
• UDI-Device Identifier: 00889024119840
• UDI-Public: (01)00889024119840(17)321230(10)J7410198
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K934765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00625006540
• Device Lot Number: J7410198
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 03/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 107 KG