MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 60MM O.D. SIZE MM POROUS; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	08/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a total hip arthroplasty on an unknown date.Subsequently, the patient experienced pain due to loosening of the cup and screw fracture.However, no revision has been reported to date.Attempts have been made and additional information on the reported event is unavailable.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog number: 00875706001, lot number: 64049358 brand name: acetabular shell, catalog number: 00885101440, lot number: 63831459 brand name: acetabular liner , catalog number: 00786401400, lot number: 63985581 brand name: femoral stem, catalog number:00877504001, lot number: 2935332 brand name: femoral head, catalog number:00625006530, lot number: 64047518 brand name: bone screw.Multiple reports were submitted along with this report 0002648920-2022-00138.Customer has indicated that the product will not be returned to zimmer biomet for investigation as the device remains implanted in the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.Initial report should be voided.
Event or Problem Description
Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.

• Brand Name: 60MM O.D. SIZE MM POROUS
• 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: 14641972
• Report Number: 0001822565-2022-01682
• Device Sequence Number: 5720872
• Product Code: LPH
• UDI-Device Identifier: 00889024151499
• UDI-Public: (01)00889024151499(17)310528(10)64049358
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: 00875706001
• Device Lot Number: 64049358
• 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: 05/13/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2018
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown