MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 40/0, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEADS

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Implant Pain (4561)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical product: catalog#: 00771101140; lot#: 63201856; femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 11 extended offset reduced neck length.Catalog#: 00875101240; lot#: 64551639; liner neutral 40 mm i.D.Siz.E kk for use with 56 mm o.D.Size kk shell.Catalog#: 00875705601; lot#: 64630388; shell with cluster holes porous 56 mm o.D.Size kk for use with kk liners.The manufacturer received source document, surgical report for review.Theses will be reviewed as part of ongoing investigation.The manufacturer did not receive x-rays.The manufacturer did not receive the device for investigation, as still implanted.The lot number of the device was received.The device history records will be reviewed during investigation.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 the patient experienced severe pain and was diagnosed with trochanteric bursitis approximately 6 months post implantation.The surgeon recommended physical therapy, rest, and ice.The outcome was tolerated, and the patient showed improvement at the 1 year follow up with moderate pain.
Additional Manufacturer Narrative
Investigation results were made available.1.Event description: it was reported that the patient underwent initial right total hip arthroplasty performed (b)(6) 2020.Subsequently, at the 6 month follow up, the patient reported severe pain and was diagnosed with trochanteric bursitis.The surgeon recommended physical therapy, rest, and ice.The outcome was tolerated, and the patient showed improvement at the 1 year follow up with moderate pain.Harm: s3 - pain or ache, moderate hazardous situation: reported issue is not device related.2.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.Medical records: medical records were provided and reviewed by a health care professional.Review of the available records identified the following: the patient underwent an initial total hip arthroplasty on (b)(6) 2020 due to osteoarthritis.Zimmer biomet components were implanted without any complications.Subsequently, the patient had severe pain and trochanteric bursitis.The physician recommended seeing a pt along with icing the hip and more rest.No other finding/complication related to the reported event was noted.3.Product evaluation: the product was not returned; therefore, device evaluation could not be performed.4.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that 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 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.5.Conclusion: it was reported that the patient underwent initial right total hip arthroplasty performed (b)(6) 2020.Subsequently, at the 6 month follow up, the patient reported severe pain and was diagnosed with trochanteric bursitis.The surgeon recommended physical therapy, rest, and ice.The outcome was tolerated, and the patient showed improvement at the 1 year follow up with moderate pain.The quality records show that all specified characteristics have met the specifications valid at the time of production.In addition, the sterilization certificate was reviewed and found to be according to specification.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).The investigation revealed no evidence that the femoral head could have led or contributed to the reported event.It is possible that patient- and/or procedure-related factors led to the reported event.Nonetheless, based on the information provided, no specific cause could be determined.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, M, 40/0, TAPER 12/14
• Common Device Name: BIOLOX DELTA CERAMIC FEMORAL HEADS
• 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: 12758197
• Report Number: 0009613350-2021-00560
• Device Sequence Number: 14958909
• Product Code: LZO
• UDI-Device Identifier: 00889024430402
• UDI-Public: 00889024430402
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-040-02
• Device Lot Number: 3009340
• 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: 10/07/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 84 KG