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

Model Number N/A

Device Problems Corroded (1131); Detachment of Device or Device Component (2907); Naturally Worn (2988)

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

Event Date 09/21/2022

Event Type  Injury  

Event Description

It was reported in a journal article that a patient underwent a revision procedure approximately eighty-seven-months post implantation due to a sharp pain.Radiographic evidence displayed ceramic insert separation and pneumarthrosis.During the revision, the capsule was found wide-open posteriorly, with a large collection of yellowish fluid, the titanium shell wear with signs of corrosion and titanium debris were observed.The ceramic liner was displaced and found mobile.The maxera cup was removed and replaced with a 4mm larger cup.The patient was observed for 8 months, and no further complications have been reported.Due diligence is in progress for this complaint; to date no additional information or product has been received.

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.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.Visual examination of the provided pictures identified two areas of metal transfer marks.No further evaluation can be made from the provided pictures.Part and lot identification are necessary for review of device history records, neither were provided.Device is used for treatment.Radiographs were provided and reviewed by a healthcare professional.Review of the available records identified the following: bilateral total hip arthroplasties with evidence of right hip ceramic liner displacement as well as pneumarthrosis.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 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: 15637303
• MDR Text Key: 302055039
• Report Number: 0009613350-2022-00552
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• 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: 11/16/2022

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: N/A
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male