MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX OPTION, HEAD, M, 36/0, TAPER 12/14; HIP PROSTHESIS

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Pain (1994); Swelling/ Edema (4577)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.As no lot number was provided, the device history records could not be reviewed.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 Description

The patient was implanted on the right side.Subsequently, the patient reported of right leg pain, numbness, altered sensation and right foot drop.Patient also experienced two hip dislocations that were treated by closed reductions.The device remains implanted.

Manufacturer Narrative

Investigation results were made available.D10: name: liner standard 3.5 mm ; item number: 00630506036; lot: 64052188.Name: femoral stem 12/14 neck taper; item number: 00771101300; lot: 61259345.Name: shell porous with cluster; item number: 00620006022; lot: 60988014.Event description: it was reported that after a revision of a right tha, there were ongoing dvts were found in right leg, as well as hematoma.Surgical intervention performed on (b)(6) 2019 to remove groin hematoma and hip incision hematoma.Surgeon noted the hematoma were not communicated, but separate, with an approximately 1.5 liter hematoma removed from hip incision.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.Surgical report: medical records were provided and reviewed by a health care professional.Review of the available records identified that on (b)(6) 2019, an ultrasound found a thrombus in the common femoral.On (b)(6) 2019, the patient underwent a surgical procedure to remove a small hematoma from the groin and a large hematoma from the posterlateral aspect of the thigh.On (b)(6) 2019, it was noted there is no concerns regarding hip infection.On (b)(6) 2019, the patient received 4 weeks of iv cefazolin for a groin abscess/cellulitis infection of mssa with no involvement of the hip incision.Patient data: the patient is reported to have a height of 6 ft, weight of 329 lbs and a bmi of 43.41.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: document review could not be performed due to unknown product identification.Device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Conclusion: it was reported that after a revision of a right tha, there were ongoing dvts were found in right leg, as well as hematoma.Surgical intervention performed on (b)(6) 2019 to remove groin hematoma and hip incision hematoma.Surgeon noted the hematoma were not communicated, but separate, with an approximately 1.5 liter hematoma removed from hip incision.The patient developed post op complications including dvts, which required filter placement and anticoagulation therapy.As the patient developed this complication requiring additional medication to treat the dvt, this increased the patient's risk for developing the additional complication of a hematoma.The patient developed a large hematoma to the hip surgical site, which required surgical intervention to remove the hematoma.The procedure was performed on (b)(6) 2019.This patient had increased risk for this complication due to recent extensive revision procedure, post op anticoagulation therapy as well as morbid obese bmi of 43.31.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure.The development of a postoperative hematoma after a procedure can be correlated with the surgical procedure and perioperative anticoagulation therapy to prevent dvt (prophylaxis).Patients may be at increased risk for developing hematomas if they have received fresh-frozen plasma, vitamin k, or hormonal therapy as well.Most hematomas resolve on their own, without surgical intervention, while some others do not.Larger hematomas may need to be surgically evacuated in order to resolve.As time frames of onset differ due to individual contributing factors, a specific time frame of expected occurrence cannot be established.Based on the investigation the reported event can be confirmed.Due to significant lack of information a detailed investigation could not be performed, nevertheless based on the given information there is no indication of a nonconformance or complaint out of box (coob).Based on the given information and the results of the investigation, we determined that the root cause of the reported issue to be unrelated to the implanted zimmer biomet devices.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 (b)(4).

Event Description

Investigation has been completed.

• Brand Name: BIOLOX OPTION, HEAD, M, 36/0, TAPER 12/14
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12630450
• MDR Text Key: 276359704
• Report Number: 0009613350-2021-00528
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024430525
• UDI-Public: 00889024430525
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 00-8777-036-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/14/2021
• Supplement Dates Manufacturer Received: 11/26/2021
• Supplement Dates FDA Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 149 KG