MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX OPTION, HEAD, M, 40/0, TAPER 12/14; BIOLOX OPTION, HEAD, M, ø 40/0, TAPER 12/14

Model Number	N/A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: liner standard 3.5 mm offset 40 mm i.D.For use with 62 mm o.D.Shell; catalog no#: 00630506240; lot#: unknown.Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 20 standard offset; catalog no#: 00771102000; lot#: 60540977.Bone screw self-tapping 6.5 mm dia.60 mm length; catalog no#: 00625006560; lot#: unknown shell porous with cluster holes 62 mm o.D.; catalog no#: 00620006222; lot#: 61316064.Therapy date: (b)(6) 2018.The manufacturer received documents for review.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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 surgery due to infection.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Event summary: it was reported that patient was implanted on the left side and underwent revision surgery due to infection that occurred less than a month post implantation.Review of received data: patient had a bilateral tha performed on (b)(6) 2010 and was revised on (b)(6) 2018 due to elevated metal ion level, metallosis and pain.A week and a half post this revision surgery there were complications to the incision line, draining wound and delayed healing.Another revision surgery was conducted where the head and liner wee exchanged due to infection.Patient also underwent a revision surgery on the right side as well on (b)(6) 2019 due to pain and elevated metal ion levels and surgeon reported metallosis and in-vivo corrosion of the same.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 was approved by zimmer biomet.Dhr review of product could not be performed as no lot# was reported.Conclusion summary: it was reported that patient was implanted on the left side and underwent revision surgery due to infection that occurred less than a month post implantation.In-vivo time of the device is 21 days.The investigation results did not identify a non-conformance or a complaint out of box (coob).Based on the available information, we were not able to identify an exact root cause for this issue.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, 40/0, TAPER 12/14
• Common Device Name: BIOLOX OPTION, HEAD, M, ø 40/0, TAPER 12/14
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9424779
• Report Number: 0009613350-2019-00788
• Device Sequence Number: 2207777
• Product Code: LZO
• UDI-Device Identifier: 00889024430563
• UDI-Public: 00889024430563
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-040-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 03/24/2020
• 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