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

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical devices: item number: 00151504636, item name: liner and shell with plastic barrier 36 mm i.D.46 mm o.D., lot # 63028144.Item number: 00771100440, item name: femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 4 extended offset reduced neck length, lot # 62797379.The manufacturer did not receive devices, x-rays, or other source documents for review as the patient has not been revised.No surgical report or x-rays were provided for review.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.Attempts to obtain additional information have been made; however, no more is available.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.Zimmer's reference number of this file is (b)(4).Note: this is a split case with zimmer inc., warsaw reference number (b)(4)., 0001822565-2021-00863 and 0001822565-2021-00864.
Event or Problem Description
It was reported the patient underwent a right hip procedure on (b)(6) 2015.Subsequently, the patient alleges onset of groin pain on (b)(6) 2020.No revision surgery has taken place yet.
Event or Problem Description
Investigation results are now available.
Additional Manufacturer Narrative
Investigation results were made available.Additional: h2, h6.Correction: b4, b5, g3, g6, h10.1.Event description: it was reported the patient underwent a right hip procedure on (b)(6) 2015.Subsequently, the patient alleges onset of groin pain on (b)(6) 2020.Harm: s2 - pain or ache, minor.Hazardous situation: unknown.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: initial operative note provided in finnish with redacted information.Op note was translated and reviewed with no complication noted.3 x-rays attached also within the medical record, which all appear from the initial operative timeframe.As the reported event of pain occurred approximately 5 years later, review of these images would not support investigation as it does not represent current review of the implants.3.Product evaluation: no product was returned; as the device remains implanted.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.5.Conclusion: it was reported the patient underwent a right hip procedure on (b)(6) 2015.Subsequently, the patient alleges onset of groin pain on (b)(6) 2020.The device remains implanted.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 non-conformance or a complaint out of box (coob).Pain cannot be related to a single specific failure mode.Further, based on the medical records provided the reported event of pain cannot be confirmed.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 cmp-(b)(4).

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 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: 11662969
• Report Number: 0009613350-2021-00168
• Device Sequence Number: 3097259
• Product Code: LZO
• UDI-Device Identifier: 00889024430358
• UDI-Public: 00889024430358
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 09/27/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-036-01
• Device Lot Number: 2795921
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 09/27/2021
• 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: Other
• Patient Age: 60 YR
• Patient Weight: 70