MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 40/-3.5, TAPER 12/14; BIOLOX DELTA CERAMIC FEMORAL HEAD

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Limited Mobility Of The Implanted Joint (2671)
Date of Event	10/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy date: detail of product: item number 00151505240; item name liner and shell with plastic barrier 40 mm i.D.52 mm o.D.Do not remove ceramic liner do not reposition cup after final seating; lot # 62798480.Item number 65771101000; item name femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 10 standard offset; lot # 62688199.The manufacturer did not receive x-rays, or other source documents for review, neither the device has been received for investigation as the patient has not been revised.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.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 patient was experiencing disabling pain, some difficulties with adls, difficulty ambulating and started to be monitored.
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.Event description: it was reported that patient underwent right tha on (b)(6) 2015 and at the one-year visit, (b)(6) 2016, the patient was experiencing disabling pain, some difficulties with adls, moderate limp detected by patient and difficulty in ambulating.Review of received data: ap view pelvis x-rays one right after op and one dated (b)(6) 2015 are received.None of the mshow any abnormalities related to the ceramic head.Head is centered in the acetabular cup.Crf report is reviewed assessing the patient condition up to 3-year post-op.No specific results noticed which could be directly related to the ceramic head.Moreover, last visit dated (b)(6) 2018 states that mild pain and moderate limp continues but patient is satisfied and sometimes participates in mild activities.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.Conclusion: review of the device history records for the product did not identify any deviations or anomalies related to the reported event.The investigation results did not identify a non-conformance or a complaint out of box (coob).With the information available at the hand it is not possible to find the root cause of the reported event.There is no information that suggests that the device caused or contributed to the patient's condition.Based on the given information the complaint could not be confirmed.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).
Event or Problem Description
Please refer toreport 0009613350-2019-00134.

• Brand Name: BIOLOX DELTA, CERAMIC FEMORAL HEAD, S, 40/-3.5, 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: 8420864
• Report Number: 0009613350-2019-00134
• Device Sequence Number: 277605
• Product Code: LZO
• UDI-Device Identifier: 00889024430396
• UDI-Public: 00889024430396
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K071535
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019

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: 02/22/2019
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-040-01
• Device Lot Number: 2654556
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/16/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 09/05/2019
• 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 Age: 52 YR
• Patient Weight: 92