MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX OPTION HEAD M 28/0, TAPER 12/14

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: durasul constrained insert size 28mm/51mm ; part#438028051; lot#63706028, therapy date: (b)(6) 2019.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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 was implanted on the left side and underwent revision due to dislocation.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.During the investigation tasks, it was noticed that the device here reported is actually the device which was implanted during the revision surgery on (b)(6) 2019.Identification of the explanted devices remain unknown.Furthermore, warsaw reported an unknown head in their complaint (b)(4) (mdr report 0001822565-2019-05345).This is why this complaint is going to be invalidated.Please void this report from your database.Zimmer biomet¿s reference number of this file is (b)(4).
Event or Problem Description
During the investigation tasks, it was noticed that the device here reported is actually the device which was implanted during the revision surgery on (b)(6) 2019.Identification of the explanted devices remain unknown.Furthermore, warsaw reported an unknown head in their complaint (b)(4) (mdr report 0001822565-2019-05345).This is why this complaint is going to be invalidated.Please void this report from your database.

• Brand Name: BIOLOX OPTION HEAD M 28/0, TAPER 12/14
• Common Device Name: BIOLOX OPTION HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9509711
• Report Number: 0009613350-2019-00813
• Device Sequence Number: 10877534
• Product Code: LZO
• UDI-Device Identifier: 00889024430440
• UDI-Public: 00889024430440
• 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 Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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 Model Number: N/A
• Device Catalogue Number: 00-8777-028-02
• Device Lot Number: 2981706
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/12/2020
• 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