MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX OPTION, HEAD, XL, 36/+7, TAPER 12/14; HIP PROSTHESIS.

Model Number	N/A
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	04/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent a revision procedure of the right hip approximately seven years post implantation due to multiple dislocations.During the revision, the following observations were noted: ruptured fascia layer, capsule and short external rotators deficient, instability, poor tissue tension, and proximal femur fracture while removing stem.The stem, head and polyethylene liner were exchanged, and cerclage wire placed on femur.The shell remained implanted.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: 36mm i.D.7mm offset size ll liner use with 58mm o.D.Size ll shell; item# 00875401336; lot# 62458709.Extended neck offset size 14 x 149mm stem length 12/14 neck taper standard body collarless uncemented femoral stem; item# 00786401420; lot# 62645373.58mm o.D.Size ll porous uncemented with cluster holes shell use with ll liners; item# 00875705801; lot# 62945530.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient had and initial right total hip arthroplasty, subsequently had multiple dislocations and was revised twice.During the revision noted ruptured fascia layer, capsule and short external rotators deficient, instability, poor tissue tension.The stem, head and polyethylene liner were exchanged, and cerclage wire placed on femur.Ruptured fascia layer with remnants found anteriorly and posteriorly.Capsule and short external rotators deficient posterior which is consistent with previous surgery and instability.Device is used for treatment.A definitive root cause could not 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.

• Brand Name: BIOLOX OPTION, HEAD, XL, 36/+7, 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: 14614052
• Report Number: 0009613350-2022-00323
• Device Sequence Number: 4638175
• Product Code: LZO
• UDI-Device Identifier: 00889024430549
• UDI-Public: (01)00889024430549(17)240531(10)2759156
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K073567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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
• Report Date (Section B): 09/05/2022

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: Lay User/Patient
• Device Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-036-04
• Device Lot Number: 2759156
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2014
• 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: Hospitalization; Required Intervention
• Patient Sex: Male