MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. SIZE LL ELEVATED RIM LINER USE WITH 58MM O.D. SIZE LL SHELL; PROTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Joint Dislocation (2374)
Date of Event	05/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient was implanted with non- zimmer biomet products.The non-zimmer biomet products were revised for an unknown reason, and the patient was implanted with the arcos stem.The arcos stem was undersized due to an iatrogenic error on the surgeon¿s behalf during the first revision (non-zb to zb products).The patient was revised due to the stem under sizing and dislocation that occurred due to the stem under sizing.There was no need to adjust the acetabular side as it remained stable.
Additional Manufacturer Narrative
(b)(4).D10: 11-301353 arcos con sz c hi 80mm 590390.00223200204 integral short gtr w/ 2 cables 56705650.00625006550 bone screw self-tapping 6.5 mm dia.50 mm length 64084511.00625006550 bone screw self-tapping 6.5 mm dia.50 mm length j7307819.00875705802 58mm o.D.Size ll porous uncemented with multi-holes shell use with ll liners 63290514.31-323240 3.2mmx40mm rnglc+ acet drl bit 233750.31-323260 3.2mmx60mm rnglc+ acet drl bit 597010.650-0662 delta ceramic fem hd 36/+3mm 3062848.310.250s drill bit 2.5mm, l 110/85mm 2-flute, f/quick coupling 9l85899 depuy.G2: foreign: australia multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 01338.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.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.No product was returned, or pictures provided; therefore, visual and dimensional evaluations could not be performed.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: subsequent to this, revision was performed.There is a dislocation of the right hip arthroplasty.Extensive radiolucency along the proximal femoral stem is present as noted.Device history record (dhr) was reviewed for deviations and/ or anomalies with no related deviations / anomalies identified.A definitive root cause cannot be determined.If any further information is received which would change or alter any conclusions or information, a supplemental 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: 36MM I.D. SIZE LL ELEVATED RIM LINER USE WITH 58MM O.D. SIZE LL SHELL
• Common Device Name: PROTHESIS, 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: 17128660
• Report Number: 0001822565-2023-01627
• Device Sequence Number: 7434554
• Product Code: LZO
• UDI-Device Identifier: 00889024149816
• UDI-Public: (01)00889024149816(17)240229(10)64239463
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K093846
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2023

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: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 00875201336
• Device Lot Number: 64239463
• 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: 05/19/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 80 KG