MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 40/-3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy date.Detail of product: - item number 00875101240; item name liner neutral 40 mm i.D.Size kk for use with 56 mm o.D.Size kk shell; lot # 63250050.- item number unknown; item name unknown stem; lot # unknown.- item number unknown; item name unknown cup; lot # unknown.The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned 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
It was reported that patient underwent revision surgery on an unknown date due to infection.
Additional Manufacturer Narrative
Concomitant medical products: medical products and therapy date.Detail of product: item number: 0100101915, item name: wagner sl revision® hip stem, uncemented, 15/190, taper 12/14, lot#: 2961181, item number: 00875705601, item name: shell with cluster holes porous 56 mm o.D.Size kk for use with kk liners, lot#: 63835582.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: additional: age or date of birth, date of event, explant date, if follow-up, what type.Correction: date of report, implant date, pma/510k.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
Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.Dhr review: ref:00-8775-040-01 ; lot: 2953537.Yield: 100.Delivered: 100.The device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: medical : revision due to infection.Event description: it was reported that 69 years old patient received left thr including biolox delta head on (b)(6) 2018 and underwent revision surgery on (b)(6) 2019 due to infection.Head and liner were revised.Review of received data: x-rays: pelvic overview: hand-measured cup inclination angle on the right approximately 56 degree, on the left 55 degree.Periarticular ossification right and left adjacent to the edge of the acetabulum and to the greater trochanter.Bone density formation adjacent to the lesser trochanter.Left hip ap-view: comparing to the pelvic overview no obvious change in findings.Left hip lauenstein-view: clearly recognizable heterotopic ossification.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.Surgical technique is not reviewed as it does not provide information to assess reported event of infection.Sterilization certificate for biolox delta head was reviewed.The sterilization certificate confirms that the product was sterilized according to the specifications.Conclusion summary: head and liner of the thr were revised during the op due to infection after 1 month in-vivo time.Review of the device history records for the product did not identify any deviations or anomalies related to the reported event.The investigation results did not identify a non-conformance or a complaint out of box (coob).Radiologically no implant-associated causes that could have led to revision surgery of the left hip due to infection on (b)(6) 2019 can be seen.Sterilization specification of the device certifies the suitability of sterilization.Sterilization certificate is reviewed.The sterilization certificate confirms that the product was sterilized according to the specifications.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level of 1.0 x 10-6 or better.Therefore, it is not suspected that the product caused or contributed to any patient infection.Based on the given information and the results of the investigation the complaint could not be confirmed.An exact root cause could not be determined.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).The following reports are associated with this event: (b)(4).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 40/-3.5, TAPER 12/14
• Common Device Name: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8342426
• Report Number: 0009613350-2019-00074
• Device Sequence Number: 14030335
• Product Code: LZO
• UDI-Device Identifier: 00889024430396
• UDI-Public: 00889024430396
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00877504001
• Device Lot Number: 2953537
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 02/22/2019; 07/26/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/22/2019; 07/30/2019
• 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
• Patient Age: 69 YR