MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM COCR MOD HD -6MM; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Off-Label Use (1494); Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient underwent initial hip arthroplasty.Subsequently, the patient was revised due to pain, acetabular component loosening, and soft tissue impingement caused by incompatible head and liner component implantation.The cup.Liner and head were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant products: 20113204 65038188 g7 longevity 10deg lnr 32mm d; 010000662 6911125 g7 pps ltd acet shell 50d; unknown stem.Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown.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: 0001825034 - 2022 - 00239.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
It was reported the patient underwent initial hip arthroplasty.Subsequently, the patient was revised approximately 7 months post implantation due to pain, acetabular component loosening, and soft tissue impingement caused by incompatible head and liner component implantation.The cup.Liner and head were removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Reported event was confirmed by review of photographs received.Visual examination of the provided pictures identified a size 36mm head was used with a size 32mm liner and a g7 cup.No other information can be obtained from the image.The device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The root cause of the reported issue is attributed to the mismatched head and liner combination used, a 32mm liner is not designed to use a 36mm head as it would not seat in the liner appropriately.A definitive root cause cannot be determined for the loose cup.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: 36MM COCR MOD HD -6MM
• 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: 13423902
• Report Number: 0001825034-2022-00238
• Device Sequence Number: 3991929
• Product Code: LPH
• UDI-Device Identifier: 00887868307935
• UDI-Public: (01)00887868307935(17)310416(10)937920
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K032396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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,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: 11-363660
• Device Lot Number: 937920
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 02/02/2022; 03/25/2022
• Initial Report FDA Received Date: 02/02/2022
• Supplement Report FDA Received Date: 02/03/2022; 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Unknown