MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX OPTION, HEAD, XL, 40/+7, TAPER 12/14

Model Number	N/A
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: e-poly 40mm +3 hiwall lnr sz24; item#ep-108524; lot#832510; mehn lt triflange sz 24; item#pm0002776; lot#874690; unk apr stem; item# unknown; lot# unknown.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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 an unknown side and underwent revision due to infection.
Additional Manufacturer Narrative
This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.Additional and corrected information are filled in the following fields: correction: b4 - d7 - g4 - g7 - h10.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
Please refer to report 0009613350-2020-00044.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay updated and additional information.Event summary: it was reported that the patient was implanted with product on (b)(6) 2019 and underwent revision surgery on (b)(6) 2020 due to infection.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.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: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Raw material certificate reviewed.The review showed that the materials were manufactured according to specification.Sterilization certificate reviewed.The review showed that the devices were sterilized according to specification.  conclusion summary : it was reported that the patient was implanted with product on (b)(6) 2019 and underwent revision surgery on (b)(6) 2020 due to infection.In vivo time of the device is 1 month.The investigation results did not identify a non-conformance or a complaint out of box (coob).However, 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, XL, 40/+7, TAPER 12/14
• Common Device Name: BIOLOX OPTION, HEAD, XL, 40/+7, TAPER 12/14
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9669494
• Report Number: 0009613350-2020-00044
• Device Sequence Number: 11491376
• Product Code: LZO
• UDI-Device Identifier: 00889024430587
• UDI-Public: 00889024430587
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2020

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: 00-8777-040-04
• Device Lot Number: 2947414
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 03/17/2020; 03/31/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/18/2020; 03/31/2020
• 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