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

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Human-Device Interface Problem (2949)

Patient Problem Joint Dislocation (2374)

Event Date 04/22/2022

Event Type  Injury  

Event 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.

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 Description

No further event information available at the time of this report.

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
• Type of Device: 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
• MDR Text Key: 293429650
• Report Number: 0009613350-2022-00323
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430549
• UDI-Public: (01)00889024430549(17)240531(10)2759156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073567
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/07/2022
• Supplement Dates Manufacturer Received: 09/01/2022
• Supplement Dates FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male