MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN BIOLOX DELTA TAPER LINER; HIP PROSTHESIS

Model Number UNKNOWN

Device Problems Corroded (1131); Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

Patient Problems Failure of Implant (1924); Pain (1994); Metal Related Pathology (4530)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: unknown biolox delta femoral head 48mm; unknown maxera 58mm acetabulum.Report source ¿ foreign ¿ canada.Journal: liner dissociation in a large-diameter ceramic-bearing acetabular component: a report of five caseslazaros kostretzis, sagi martinov, martin lavigne, vincent massé, pascal-andré vendittoli: bmc musculoskeletal disorders (2022); https://doi.Org/10.1186/s12891-022-05082-6.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported in a journal article that the patient underwent a revision procedure approximately 5 and 1/2 years post implantation due to abrupt pain in the left groin and buttock region.Radiographic evidence displayed millimetric separation of the ceramic insert and pneumarthrosis.During the revision, the ceramic liner was found misaligned.During extraction of the acetabular component, it was impossible to separate the ceramic liner from the titanium shell.Taper modular junction wear and corrosion signs were observed, without metallosis.A 4mm larger than the index, maxera component was implanted.The patient followed standard post-operative rehabilitation without further complications.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h6, h10.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Device is used for treatment.Complaint history review cannot be performed without product identification.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN BIOLOX DELTA TAPER LINER
• 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: 15637305
• MDR Text Key: 302056555
• Report Number: 0009613350-2022-00528
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2022
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male