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
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Pneumonia (2011)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: shell with cluster holes porous 54 mm o.D.Size jj for use with jj liners; catalog#: 00-8757-054-01; lot#: 64819002.Liner elevated rim 36 mm i.D.Size jj for use with 54 mm o.D.Size jj shell; catalog#: 00-8752-011-36; lot#: 64671798.Femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 12.5 extended offset reduced neck length; catalog#: 00-7711-012-40; lot#; 64846601.Therapy date: unknown 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.(b)(4).
Event or Problem Description
It was reported that the patient underwent an initial right total hip arthroplasty and experienced postop pneumonitis requiring additional intervention and prolonged hospitalization.The complication resolved by postop day 2.Upon follow up, the patient had minimal pain and problems.
Additional Manufacturer Narrative
Investigation results were made available.1.Event description: it was reported that initial right total hip arthroplasty was performed (b)(6) 2021.Subsequently, it was reported that the patient experienced postop pneumonitis requiring additional intervention and prolonged hospitalization.The complication resolved by postop day 2.Upon follow up, the patient had minimal pain and problems and was very satisfied harm: s3 - infection, moderate localized hazardous situation: unknown.2.Review of received data: due diligence: further due diligence to support the conclusion was completed and documented.Surgical report: several documents have been provided for review.(b)(6) 2020: pre-op examination.No information related to the reported event provided.(b)(6) 2020: surgery scheduling document: no information related to the reported event provided.(b)(6) 2021: implantation report: anesthesia record: anesthesia post evaluation: patient informed that likely aspirated due to left lung pneumonia on cxr.(b)(6) 2021: case report: no information related to the reported event provided.(b)(6) 2021: hospital consultation: at risk for respiratory complications from intubation and respiratory suppression from opioids postop.Possible aspiration: patient with possible aspiration in or.Mild cough in pacu, no fevers or chills.Cxr with possible left infiltrate, noted again today.Wbc noted at 20k but no bandemia.Still on oxygen this morning.Looks good but with wbc and persistence of possible infiltrate will place on cefepime.Could be noninfectious (pneumonitis).(b)(6) 2021: physical therapy: no information related to the reported event provided.(b)(6) 2021: discharge summary: no information related to the reported event provided.(b)(6) 2021: 1m post op exam: no information related to the reported event provided.(b)(6) 2021: 3m post op exam: no information related to the reported event provided.3.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.4.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Sterilization certificate: the eto/ gamma sterilization specification of the device certifies the suitability of sterilization.5.Conclusion: it was reported that initial right total hip arthroplasty was performed (b)(6) 2021.Subsequently, it was reported that the patient experienced postop pneumonitis requiring additional intervention and prolonged hospitalization.The complication resolved by postop day 2.Upon follow up, the patient had minimal pain and problems and was very satisfied based on the investigation the reported event can be confirmed.Within anethesia record of implantation procedure it is stated that the patient was informed that he likely aspirated due to left lung pneumonia on cxr.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).Also, within the provided clinical information there is no aspect which points into the directed that the reported device caused or contributed to the reported event.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for this issue.However, the most likely root cause for the reported error pattern is aspiration during implantation.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet's reference number of this file is (b)(4).
Event or Problem Description
Investigation results are now available.

• 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
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 12546466
• Report Number: 0009613350-2021-00504
• Device Sequence Number: 16361782
• Product Code: LZO
• UDI-Device Identifier: 00889024430372
• UDI-Public: 00889024430372
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00877503603
• Device Lot Number: 3048026
• 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: 08/31/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 92 KG