MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX OPTION, HEAD, XL,40/+7, TAPER 12/14; BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES

Model Number	N/A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products and therapy date detail of product: item number: 010000667, item name: g7 pps ltd acetabular shl 60g, lot #: 6320942.Item number: 00771101520, item name: femoral stem 12/14 neck taper plasma sprayed press-fit cementless size 15 extended offset, lot #: 63989050.Item number: 110017226, item name: g7 neu +5mm e1 liner 40mm g g, lot #: 6429250.Item number: 00625006540, item name: bone screw self-tapping 6.5 mm dia.40 mm length, lot #: 64426269.Item number: 31323240, item name: 3.2mm*40mm rnglc + acet drl bit, lot #: 570990.The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is 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.(b)(4).
Event or Problem Description
It was reported that patient underwent revision surgery due to unknown reason.
Additional Manufacturer Narrative
Event summary: it was reported a patient (bmi=33.2) underwent a right hip arthroplasty on (b)(6) 2019 and was revised on (b)(6) 2019 due to recurrent dislocations.Patient then underwent another revision due to dislocation on (b)(6) 2019.Review of received data three x-rays of the right hip received dated (b)(6) 2019.No anomalies noted.Positioning of implants appear adequate.Surgical report of primary surgery dated (b)(6) 2019 received.Indication for surgery was osteoarthritis in the right hip.Bone quality noted as being excellent.A femoral neck osteotomy was made 15mm above the lesser trochanter, based on the preoperative template.The hip was noted as having satisfactory motion and stability.Implantation labels provided.Surgical report of revision surgery dated (b)(6) 2019 received.Indication for surgery was instability of the right total hip arthroplasty.Surgeon could not dislocate the hip.However, performing a shucking maneuver produced about 7-8 mm of shuck and laxity in the hip.Surgeon noted this as being different from the primary procedure and likely represents some soft tissue stretching ad this resulting in laxity.Surgeon noted that this could be the cause of instability and the dislocations, where the laxity in the shuck could allow the femoral head to sublux inferiorly and then depending on twisting or maneuvering, could cause it then to dislocate.Positioning of cup noted as being appropriate.No more shuck noted after implantation of new femoral head.No apparent complications noted.Implantation labels provided.Surgical report of revison surgery dated (b)(6) 2019 received.Indication for revision surgery was dislocation.Patient was standing by his pickup trick and dislocated his hip.A large hematoma was evacuated from hip joint.Femoral component well-fixed, not revised.Acetabular liner was removed with osteotomes.Acetabular components well-fixed.Initially, the dual-mobility construct were implanted.However, the hip was not stable during reduction.Therefore, the surgeon decided to switch to a cemented constrained liner.Metal liner was not coming out with the extraction tool, therefore osteotomes and a bur was used to dislodge the liner and eventually this was able to be removed with very little damage to the acetabular component.Cemented trilogy liner was cemented into place.Hip was reduced and found stable.Implantation labels provided.Office visit noted received dated (b)(6) 2019.Patient symptoms of pain remain unchanged since primary surgery.Patient sustained another dislocation over the weekend whilst standing in and turning slightly, but without a significant maneuver that is generally associated with a dislocation.Patient was reduced in the er.List of past medical and surgical history provided, including lumbar spinal surgery 12-24 months ago, ls spine surgery in 2014, meniscectomy of the left and right knee 24+ months ago and a total knee replacement of the right knee 5+ years ago.Imaging of the right hip reveal good prosthesis alignment.Office visit noted received dated (b)(6) 2019.Patient has been experiencing pain post-operatively.No signs of swelling, no experiencing of numbness.Patient had some issues with skin healing and had some oozing from the tissues, which was not coming from the incision.Post operative radiographs reveal good prosthesis alignment.Devices 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 from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Conclusion summary it was reported a patient (bmi=33.2) underwent a right hip arthroplasty on (b)(6) 2019 and was revised on (b)(6) 2019 due to recurrent dislocations.Patient then underwent another revision due to dislocation on (b)(6) 2019.The investigation results did not identify a non-conformance or a complaint out of box (coob).The surgical report of the revision surgery dated (b)(6) 2019 states that performing a shuck maneuver, about 7-8 mm of shuck and laxity was produced in the hip.The surgeon notes this likely represents some soft tissue stretching and this resulting in laxity.Surgeon noted that this could be the cause of instability and the dislocations, where the laxity in the shuck could allow the femoral head to sublux inferiorly and then depending on twisting or maneuvering, could cause it then to dislocate.However, post implantation of the new componets, it was stated by the surgeon that there was no longer any shuck that could be demonstrated except with really extreme shucking by the assistant across the table, whereby the full body weight onto the hip is pic, at which point about 3 mm of shuck could be achieved.Additionally, in the office visit notes received, a list of patient past medical and surgical history was provided, which could have contributed to the recurrent dislocations, including lumbar spinal surgery as well as knee surgeries.Office notes prior to the revision surgery dated (b)(6) 2019 mention post-operative radiographs revealing good prosthesis alignment.Moreover, possible root causes for a dislocation include wrong head offset choice, inadequate assembling procedure, high patient activity, inadequate information during patients counseling by surgeon leading to premature failure caused by patient behavior, patient disregarding the limits of the device or joint laxity.Based on the available information, a definite 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).
Event or Problem Description
No change to previously reported event.

• Brand Name: BIOLOX OPTION, HEAD, XL,40/+7, TAPER 12/14
• Common Device Name: BIOLOX OPTION CERAMIC FEMORAL HEAD SYSTEM, MODEL 8777 SERIES
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 9165244
• Report Number: 0009613350-2019-00594
• Device Sequence Number: 2774357
• Product Code: LZO
• UDI-Device Identifier: 00889024430587
• UDI-Public: 00889024430587
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K073567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-040-04
• Device Lot Number: 2693572
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 04/28/2020
• 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: Hospitalization; Required Intervention
• Patient Weight: 121