MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX OPTION, HEAD, M, 32/0, TAPER 12/14

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive x-rays, or other source documents for review.Where lot numbers were received for the devices, the device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
Patient underwent closed reduction under sedation due to post revision recurrent dislocation.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Event summary: it was reported that the patient underwent initial right total hip arthroplasty performed (b)(6) 2007.Subsequently, the patient was revised on (b)(6) 2016 due to pain, elevated metal ions, and metallosis complications.After the revision, the patient experienced recurrent dislocations requiring closed reductions under sedation.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment.The compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination (shell, liner and head) was approved by zimmer biomet.Nevertheless, due to missing stem identification the compatibility of the head and the stem could not be performed.Dhr review: the quality records show that all specified characteristics have met the specifications valid at the time of production.Conclusion summary : it was reported that the patient underwent initial right total hip arthroplasty performed (b)(6) 2007.Subsequently, the patient was revised on (b)(6) 2016 due to pain, elevated metal ions, and metallosis complications.After the revision, the patient experienced recurrent dislocations requiring closed reductions under sedation.The device was not returned for evaluation as it remained implanted, therefore visual and dimensional evaluation could not be performed.Due to missing stem identification the compatibility of head and stem could not be reviewed.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation results did not identify a non-conformance or a complaint out of box.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: patient underwent an initial right tha on (b)(6) 2007 and no complications were noted.Later patient was revised on (b)(6) 2016 due to elevated metal ions, metallosis, corrosion and other complications.Post-revision patient experienced multiple dislocations.Patient was reclining in an car seat and dislocated, was reduced in the er; dislocated again in an office chair, attempted reduction that quickly dislocated again and was reduced again under iv sedation.Otherwise, no medical records such as x-rays have been received.The reasons for hip dislocations are multifactorial, with contributing factors from the patient, the implant, and the surgical procedure.In conclusion, based on the given information no exact root cause could be identified.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
No change to previously reported event.

• Brand Name: BIOLOX OPTION, HEAD, M, 32/0, TAPER 12/14
• Common Device Name: BIOLOX OPTION, HEAD, M, 32/0, TAPER 12/14
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9720121
• Report Number: 0009613350-2020-00070
• Device Sequence Number: 13544872
• Product Code: LZO
• UDI-Device Identifier: 00889024430488
• UDI-Public: 00889024430488
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K073567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2020

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: 10/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-032-02
• Device Lot Number: 2832523
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 06/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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