MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX OPTION, HEAD, L, 32/+3.5, TAPER 12/14; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	06/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient experienced a hip dislocation approximately two months post-implantation.Patient experienced a second hip dislocation approximately three months post-implantation.Due diligence is in progress for this event; to date no further information has been provided.
Additional Manufacturer Narrative
(b)(4).Italy.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Vit e liner neutral ii 32 item#00-8851-010-32, lot#64239542.This follow-up report is being submitted to relay additional and corrected information.No product was returned or pictures provided: product evaluation could not be performed.Part and lot identification are necessary for review of device history records, neither were provided, therefore no research could be performed.Device used for treatment.Of note, patient is characterized with a high bmi score, which might increase the risk of hip dislocation.However, with the available information a definitive root cause cannot be determined 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.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.D10: vit e liner neutral ii 32 item#00-8851-010-32 lot# 64239542.Continuum shell 52mm item#unknown lot# unknown.Cls stem 12.5 (winterthur) item#unknown lot# unknown.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that patient underwent a left total hip arthroplasty, approximately 5 years, 9 months post op , the head and liner were exchanged, and a second revision was performed 18 months later due to ceramic liner fracture.After the second revision, the patient continued to experience instability with frequent falls leading to recurring dislocations.The patient underwent a third revision performed approximately 4 months later during which, a constrained liner was placed.The patient had an uncomplicated revision and postoperative course and was discharged form physical therapy after successful treatment.Due diligence is in progress for this event; to date no further information has been provided.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and corrected information.A review of the additional information reported in 0009613350-2022-00555-3 does not alter the findings of the previously reported investigation.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: BIOLOX OPTION, HEAD, L, 32/+3.5, TAPER 12/14
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15651756
• Report Number: 0009613350-2022-00555
• Device Sequence Number: 2356640
• Product Code: LZO
• UDI-Device Identifier: 00889024430495
• UDI-Public: (01)00889024430495
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K073567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/23/2023

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 Model Number: N/A
• Device Catalogue Number: 00-8777-032-03
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 10/24/2022; 12/06/2022; 11/30/2022; 02/21/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 11/22/2022; 12/14/2022; 12/23/2022; 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE; SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic