MAUDE Adverse Event Report: MERETE GMBH BIOBALL DELTA CERAMIC HEAD; TOTAL HIP REPLACEMENT DEVICE

Model Number	HM50036
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Merete wasl informed that a "patient was revised due to dislocation".The liner from another manufacturer was re-placed from lipped to neutral and a bioball offset adapter was used to add offset for patient.The merete articles bioball adapter and bioball delta ceramic head were explanted.No further information was received regarding the cause of the dislocation.No further customer feedback could be provided by the distributor and the product could not be returned for further investigation.No products from the relating batch is on stock.A review of the batch record was performed and no deviations were identified.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.
Event or Problem Description
Merete wasl informed that a "patient was revised due to dislocation".The liner from another manufacturer was re-placed from lipped to neutral and a bioball offset adapter was used to add offset for patient.The merete articles bioball adapter and bioball delta ceramic head were explanted.

• Brand Name: BIOBALL DELTA CERAMIC HEAD
• Common Device Name: TOTAL HIP REPLACEMENT DEVICE
• Manufacturer (Section D): MERETE GMBH; alt-lankwitz 102; berlin, berlin 12247 ; GM 12247
• MDR Report Key: 11492237
• Report Number: 3002949614-2021-00002
• Device Sequence Number: 16858128
• Product Code: LZO
• UDI-Device Identifier: 04048266025470
• UDI-Public: (01)04048266025470(17)250305(10)701145158/03
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K123619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

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?: No
• Operator of Device: No Information
• Device Expiration Date: 03/05/2025
• Device Model Number: HM50036
• Device Catalogue Number: HM50036
• Device Lot Number: 7011451583/03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization