MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 36/+3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number	N/A
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: g7 hi-wall e1 liner 36mm f; catalog#: 010000936; lot#: 6724556.Therapy date: (b)(6) 2020.The manufacturer received other source documents for review.The manufacturer did not receive the device for investigation.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 was implanted on an unknown side and underwent revision surgery due to infection.Infection occurred less than 2 months post initial surgery.
Event or Problem Description
No change to previously reported event.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported that the patient underwent an initial hip procedure on (b)(6) 2020.The patient underwent a head and liner replacement and washout on (b)(6) 2020 due to infection.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Patient data: (b)(6) male, born (b)(6) 1950, 170 cm, 80 kg.No medical data, such as laboratory reports, have been received.Product evaluation: - no product was returned; therefore, evaluation could not be performed.Review of product documentation: - device purpose: this device is intended for treatment.- product compatibility: the compatibility check could not be performed as not all involved products are known.The reported liner and head are compatible.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.- sterilization certificate: the gamma sterilization specification of the device certifies the suitability of sterilization.The irradiation certificate of the affected lot number has been reviewed and was found to be according to specifications.Conclusion: it was reported that the patient underwent an initial hip procedure on aug 26, 2020.The patient underwent a head and liner replacement and washout on oct 21, 2020 due to infection.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).The reported event of deep infection <90 days occurred post implantation.The sterilization certificate was reviewed and found to be conforming with no applicable deviations.The biolox head was verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors,  and/or patient comorbidities/risk factors.There are no indications of a product or process issue affecting implant safety or effectiveness, therefore the implanted biolox head is not considered the source or contributing factor to the reported infection.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).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, L, 36/+3.5, TAPER 12/14
• Common Device Name: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10768659
• Report Number: 0009613350-2020-00518
• Device Sequence Number: 19855897
• Product Code: LZO
• UDI-Device Identifier: 00889024430372
• UDI-Public: 00889024430372
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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: 00-8775-036-03
• Device Lot Number: 2994025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 02/24/2021
• 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
• Patient Weight: 80