MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, XL, ø 32/+7, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number	N/A
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Surgical report was received and will be reviewed as part of ongoing 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.(b)(4).
Event or Problem Description
It was reported that a patient has been noted to have leg length discrepancy due to incorrect implant size.The patient is experiencing pain, attempts to obtain additional information have been made; however, no more is available.
Event or Problem Description
Please refer to report 0009613350-2018-01180.
Additional Manufacturer Narrative
This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: dhr review: the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trigger considering the following event is identified: pain / use of wrong size implant event description: it was reported that the patient underwent right tep on nov 10, 2014 and is experiencing pain and a discrepancy with his leg lengths (right leg is shorter).He has been to two different surgeons - dr.Gerald j jerry jr.And dr.Harry greene (from oakland orthopedics) - who told him that his implant is the wrong size, namely too short and not wide enough.This causes pinching of the nerves in the soft tissue.A revision is planned.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: this device is intended for treatment -the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Surgical technique is not reviewed as no surgical reports were received to compare.Conclusion: the investigation results did not identify a non-conformance or a complaint out of box (coob).Operative notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.No x-rays were received to confirm that the surgeon made a wrong size selection for the head.The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Based on the given information the complaint could not be confirmed.An exact root cause could not be determined.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, XL, ø 32/+7, TAPER 12/14
• Common Device Name: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8119040
• Report Number: 0009613350-2018-01180
• Device Sequence Number: 19250078
• Product Code: LZO
• UDI-Device Identifier: 00889024430341
• UDI-Public: 00889024430341
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

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 Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-032-04
• Device Lot Number: 2718902
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 06/26/2019
• 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 Weight: 89