MAUDE Adverse Event Report: ZIMMER BIOMET, INC. REGENEREX/RINGLOC+ LIMITED 52MM SIZE 23; 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 remaining in patient.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 cer bioloxd mod hd 36 mm std nk, item#: 12-115121, lot#: 2911053.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, 0001825034-2018-03018.

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.

Event Description

It was reported patient underwent a hip revision 2 days post-op due to disassociation.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

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: REGENEREX/RINGLOC+ LIMITED 52MM SIZE 23
• Type of Device: HIP PROSTHESIS
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7477732
• MDR Text Key: 107042899
• Report Number: 0001825034-2018-03017
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• PMA/PMN Number: PK070369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• 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: PT-116052
• Device Lot Number: 315700
• Other Device ID Number: 0 0880304 45144 5
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2018
• 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
• Patient Age: 64 YR
• Patient Weight: 136