MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14; HIP PROSTHESIS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Report source- foreign- china.Concomitant medical products: liner 10 degree elevated rim 32 mm i.D.For use with 50/52/54 mm o.D.Shells item#00631005032, lot#64285339; bone scr 6.5x30 self-tap item# 00625006530, lot# unknown; bone scr 6.5x25 self-tap item# 00625006525, lot# 63020289; shell porous with multi holes 52 mm item # 00620205220, lot# 64164970; standard offset size 12.5 reduced neck length 12/14 neck taper uncemented femoral stem # 00771101210, lot# 64172775.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that patient underwent an initial right total hip arthroplasty approximately three (3) years ago.Subsequently, approximately two (2) years ago, the patient reported developing pain in the right hip.The patient had an mri where infectious lesions and abscess formation in the upper femur, hip and periprosthetic soft tissue were found.Patient was admitted to hospital the following day and underwent a right hip lesion incision and exploration, debridement and dilation, internal fixation removal, device revision and tube flushing and drainage.The head and liner were removed and replaced.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.No product was returned or pictures provided: product evaluation could not be performed.A review of the manufacturing records identified no deviations or anomalies during manufacturing.The device used for treatment.X-ray were received and reviewed but did not provide any additional information as the reported event involved infection.During the investigation process a review of the sterile certifications were found to be conforming with no applicable deviations.Devices were verified to have gone through an acceptable sterilization process following published guidelines.As there are no indications of product or process issues affecting implant safety or effectiveness, it is unlikely that the implanted products are the source or even contribute to the reported infection.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.As no information is provided on the patient's medical history and the surgical technique, it is impossible to assess the relevance and the influence of these contributing factors.With the available information a definitive root cause cannot be established.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, ø 32/-3.5, TAPER 12/14
• Common Device Name: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 15957424
• Report Number: 0009613350-2022-00628
• Device Sequence Number: 5107270
• Product Code: LZO
• UDI-Device Identifier: 00889024430310
• UDI-Public: (01)00889024430310(17)290131(10)2976331
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2023

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: 00-8775-032-01
• Device Lot Number: 2976331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male