MAUDE Adverse Event Report: ZIMMER GMBH GAMMA INSERT, PE, HOODED, II/28; HIP IMPLANT

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2023

Event Type  malfunction  

Event Description

It was reported that during a surgery, the inlay ii/28 hooded could not be fixed in the cup.The equivalent made of durasul could be fixed well and was finally implanted.It was reported a delay of 60 minutes.There is no reported harm or injury to the patient.Due diligence has been completed for this complaint; to date no additional information has been received.

Manufacturer Narrative

(b)(4).G2: foreign: germany.The insert was returned for investigation.Scratches and dents are evident on the rim as well as on the articulation surface.Deep scratches are observable on the outer surface.The flat backside reveals three distinct areas of indentation, commonly caused by the three metal spikes of the shell.Multiple indentation points are visible within each area which points to multiple attempts.Additionally, deformation can be seen in one area of the edge.As described in the product experience report (per), the liner was sterilized with an autoclave before being returned to zimmer biomet for investigation.Due to the high temperature developed during steam sterilization processes, it can be assumed that the polyethylene liner is no longer in its original condition.Therefore, any dimensional analysis performed on the item would not be representative of the as-manufactured condition and does not enhance the outcome of the investigation.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Based on the available information, a definitive root cause for the reported event could not be established.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.

• Brand Name: GAMMA INSERT, PE, HOODED, II/28
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): ZIMMER 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: 18961202
• MDR Text Key: 338497946
• Report Number: 0009613350-2024-00085
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024536838
• UDI-Public: (01)00889024536838(17)240531(10)2996826
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4262209
• Device Lot Number: 2996826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2019
• 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 Age: 46 YR
• Patient Sex: Female
• Patient Weight: 64 KG