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

Device Problem Mechanical Problem (1384)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer did not receive devices for review as the patient has not been revised.X-rays or other source documents were not provided for review.As no lot numbers were provided for the device, the device history records could not be reviewed.A cause for this specific event cannot be ascertained from the information provided.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(4) legal department is well trained and passes all information concerning the case to our complaint handling department.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

A product liability claim was raised.It was reported that the patient was implanted an unknown hip component on the left side on (b)(6) 2011.The patient started to hear noises like squeaking from the hips about two month ago.It was reported that the noise can be heard also from people around the patient.Since the exact occurrence date is unknown, the date of event was left empty.Note: this is a bilateral patient.The right hip is reported under (b)(4).

Manufacturer Narrative

The manufacturer did not receive devices for review as the patient has not been revised.Implant notes, peels and sticks, lab reports, surgeon notes were received and review of them is part of the investigation process.A cause for this specific event cannot be ascertained from the information provided.As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted.Due to fact that this is a legal claim, our legal department has been provided with the available facts from the customer.Zimmer (b)(4) legal department is well trained and passes all information concerning the case to our complaint handling department.Zimmer's reference number of this file is (b)(4).

Event Description

A product liability claim was raised.It has now been reported that the patient was implanted a biolox delta, ceramic femoral head, s, 40/-3.5, taper 12/14 on the left side on (b)(6) 2011.The patient started to hear noises like squeaking from the hips about two month ago.It was reported that the noise can be heard also from people around the patient.

Manufacturer Narrative

Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Trend analysis: no trend identified.Review of event description: the patient had a bilateral hip (left and right) replacement performed on (b)(6) 2011.Since the primary surgery the patient reported that she did yearly radiographic control and that the implants were performing fine.It is then reported in a legal letter dated june 26, 2016 that the patient hears noises like squeaking from the hips (more on the right side than on the left side) since approximately 2 months.Review of received data: more than 100 pages of patient's clinical files are available for evaluation.The documents are partially hand written and parts of the documents are illegible.The review of the complete documentation can be summarized as follows: page 1-21: patient had a bilateral coxarthrosis and due to this she had bilateral hip replacement on (b)(6) 2011.The rehabilitation and all notes of the postoperative hospital stay including drug prescriptions are available (and mainly illegible).The patient had to undergo blood transfusions.The documents contain also patient consent for health insurance.A rehabilitation protocol after the bilateral hip replacement is available.Patient history is described as well as objectives, results and verification of the rehabilitation.The implantation was performed with a postero-lateral approach, no intraoperative nor local postoperative complication are reported and the cup and stem were cementless.Page 22-80: patient labels for both hips are available.A letter dated july 27, 2011 states that the patient needed blood transfusion postoperatively due to anemia.Since (b)(6) 2011 the patient is having rehabilitation.Notes of the hospital stay are available.A rehabilitation protocol after the bilateral hip replacement, evaluation and rehabilitation notes are available.Notes about the vital parameter monitoring are also available.A radiological report dated (b)(6) 2011 and one dated (b)(6) 2011 are available.Nothing conspicuous.Blood test results and electrocardiogram are also available.Page 81-101: blood tests, electrocardiogram, transfusion documents, patient consent for the surgery and a radiological report dated (b)(6) 2011 are available.Product labels are also available.Nothing conspicuous.Surgical report of implantation is available.The report describes the implantation of a ceramic on ceramic bearing with maxera cup size 50 (inclination 45°, anteversion 20°), fitmore stem b/6 and ceramic head 36mm -3.5mm with postero-lateral approach on the right side on the right hip.Afterward, the exact same procedure is described for the left hip.No conspicuousness.Page 122-133: anesthesia protocol of surgery and patient consent, as well as pre-operative check and documents regarding instrumentation and materials used in the surgery and surgery checklist, and documents about post-operative blood transfusions, blood tests are available.Additionally, a summary of the hospital stay / discharge summary of the patient is also available.No conspicuousness.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: surgical technique of maxera cup showed that the product combination (maxera cup 50mm with biolox head 40mm) was approved by zimmer biomet.Root cause determination using dfmea: noise causes patient dissatisfaction due to implant squeaks or clicks - (stripe wear) => possible: it is reported that the patient and other people hear both patient's hip squeaking/making noise.This is possibly due to stripe wear.Conclusion summary: it is reported that the patient and other people hear both patient's hip squeaking/making noise.This is possibly due to stripe wear.Other possibilities are that device malpositioning or third body are located in the articulation.However, without product, surgical reports and x-rays , it is impossible to perform a meaningful analysis of the reported event.Therefore, an exact root cause could not be determined.The need for corrective measures is not indicated and zimmer (b)(4) considers this case as closed.Zimmer's reference number of this file is (b)(4).

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, S, 40/-3.5, TAPER 12/14
• Type of Device: BIOLOX DELTA CERAMIC FEMORAL HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 5811727
• MDR Text Key: 50081050
• Report Number: 0009613350-2016-01069
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2016
• Device Model Number: N/A
• Device Catalogue Number: 00-8775-040-01
• Device Lot Number: 2590223
• Other Device ID Number: 00889024430396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 60