MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CERAMIC BIOLOXD MODULAR HEAD 36MM STANDARD NECK; HIP PROSTHESIS

Model Number N/A

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problem Joint Dislocation (2374)

Event Date 04/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to hospital discarding as biohazard.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: biomet e-poly 36 mm +3 maxrom lnr sz23, item#: ep-108223, lot#: 247000.Biomet regen/rnglc+ ltd 52 mm sz 23, item #: pt-116052, lot#: 315700.Biomet tprlc 133 fp type1 pps ho 7.0, item#: 51-101070, lot#: 2711253.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-03015, 0001825034-2018-03017.

Event Description

It was reported patient underwent a hip revision 2 days post-op due to disassociation and dislocation.No anomalies were noticed during the initial surgery, but surgeon believes patient's abnormally high body mass index was a contributing factor.No additional patient consequences were reported.Attempts to obtain additional information have been made; however, no more is available.

Manufacturer Narrative

(b)(4).This report is being submitted to relay additional information.The following sections were updated: date of report, date rec¿d by mfr.Upon receipt of additional information it has been determined that this device did not cause or contribute to the reported event.This report should be voided.

• Brand Name: CERAMIC BIOLOXD MODULAR HEAD 36MM STANDARD NECK
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7477730
• MDR Text Key: 107042151
• Report Number: 0001825034-2018-03018
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK061312
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 12-115121
• Device Lot Number: 2911053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/01/2018
• Supplement Dates Manufacturer Received: 05/08/2018
• Supplement Dates FDA Received: 05/09/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 136