MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL WITH CLUSTER HOLES POROUS 56 MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source: source: (b)(6).Concomitant medical products: catalog number:00875705601 lot number:61629493 brand name: continuum shell; catalog number: 65771101200 lot number: 61595725 brand name: m / l taper stem; catalog number: 00877501240 lot number:2523976 brand name: biolox delta ceramic liner; catalog number:00877504002 lot number:2525736 brand name: biolox delta ceramic head.Multiple reports were submitted along with this report : 0001822565-2021-03719.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.Device remains implanted in the patient.
Event or Problem Description
It was reported that the patient experienced pain approximately 10 years post implantation.Attempts have been made and additional information on the reported event is unavailable at this time.
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.
Additional Manufacturer Narrative
Upon receipt of additional information it has been determined that the reported device did not cause or contribute to the event.

• Brand Name: SHELL WITH CLUSTER HOLES POROUS 56 MM
• 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: 13124755
• Report Number: 0001822565-2021-03718
• Device Sequence Number: 17259460
• Product Code: LPH
• UDI-Device Identifier: 00889024151437
• UDI-Public: (01)00889024151437(17)201231(10)61629493
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K151448
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 01/10/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00875705601
• Device Lot Number: 61629493
• 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: 12/23/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 12/31/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2011
• 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: Other; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 82 KG