MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH BIOLOX HEAD

Model Number N/A

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problem Fall (1848)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: unknown liner; catalog#: unknown; lot#: unknown.M2a-magnum pf cup 56odx50id; catalog#: us157856; lot#: 125120.Bi-metric/x por nc 12x140; catalog \#: x180312; lot#: 637830.Therapy date: (b)(6) 2020.The manufacturer received other source documents for review.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.(b)(4).

Event Description

Patient was implanted on the left side.Two months post implantation the patient sustained a fall due to unknown reasons and experienced a dislocation.In addition, an intra-prosthetic disassociation of the ceramic head from the poly liner was also confirmed.This is the patient's second revision surgery.Patient underwent first revision surgery due to complications from metal related pathology including significant abductor muscle necrosis and metallosis.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that patient underwent initial left total hip arthroplasty (b)(6) 2007.Subsequently, the patient was revised due to complications from metal related pathology including significant abductor muscle necrosis and metallosis (see (b)(4)).Two months after the revision, the patient sustained a fall due to unknown reasons and dislocated.In addition, an intraprosthetic disassociation of the ceramic head from the poly liner was confirmed.The patient underwent a second revision on september 17, 2020 in which the dual mobility head and liner were exchanged.Harm: s3 - dislocation hazardous situation: patient's anatomy is exposed to excessive external forces postoperatively.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.Review of medical documents: medical documents were reviewed by hcp: contributing factors of event: patient previously revised due to metal related pathology which resulted in severe muscle necrosis.Loss of muscular tissue predisposes the patient to falls/instability.Findings: dx: failed left tha dual mobility component in the setting extensive abductor necrosis due to metallosis (continuation of previous finding from first revision; therefore, not called out as category for this complaint) spinal, ebl 200ml patient was doing well until he sustained fall (unknown reason) resulting in dislocation, underwent closed reduction but disengagement of ceramic head with the poly liner occurred on (b)(6) 2020, intraprosthetic dislocation confirmed with xray/ct (coded as disassociation per engineer consult) extensive necrosis of abductor involving more than 70% due to metallosis was again noted new head and liner placed without complication.Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the compatibility check could not be performed due to unknown product identification.Conclusion: it was reported that patient underwent initial left total hip arthroplasty (b)(6) 2007.Subsequently, the patient was revised due to complications from metal related pathology including significant abductor muscle necrosis and metallosis (see (b)(4).Two months after the revision, the patient sustained a fall due to unknown reasons and dislocated.In addition, an intraprosthetic disassociation of the ceramic head from the poly liner was confirmed.The patient underwent a second revision on september 17, 2020 in which the dual mobility head and liner were exchanged.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).As the explants have not been received for an investigation, the condition of the head remains unknown.The reasons for hip dislocation are multifactorial, with contributing factors from the patient, the implant, and the surgical procedure.Moreover, the most likely root cause leading to the disassociation and dislocation are the excessive forces acting on the joint during the fall of the patient in combination with severe necrosis of the surrounding structures from the previous mom components and revision.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 results are now available.

• Brand Name: BIOLOX HEAD
• Type of Device: BIOLOX HEAD
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11147368
• MDR Text Key: 226041577
• Report Number: 0009613350-2021-00005
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention