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

Model Number	HM50036
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product could not be returned and stayed with the customer.The further communication with the distributor brought up, that the patient of this case is the same as reported under 3002949614-2021-00001 with the same articles.A dhr review (including sterilization records) was performed and brought up no deviations.No packaging damage was reported by the distributor on request.The risk of infection is a known residual risk with the procedure, covered by the risk analysis and corresponding information is given in the belonging accompanying product information as a possible side effect.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
The patient was revised for infection on (b)(6) 2021.This event is the second revision of this patient, the first revision (infection) has been also recorded and reported under 3002949614-2021-00001.All implants were removed and replaced.

• 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: 12115479
• Report Number: 3002949614-2021-00003
• Device Sequence Number: 3768289
• Product Code: LZO
• UDI-Device Identifier: 04048266025470
• UDI-Public: (01)04048266025470(17)230308(10)7011237016/03
• 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 Implanted Year: 2021
• Device Explanted Year: 2021
• 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): 07/05/2021

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: Lay User/Patient
• Device Expiration Date: 03/08/2023
• Device Model Number: HM50036
• Device Catalogue Number: HM50036
• Device Lot Number: 7011237016/03
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 07/05/2021
• 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; Life Threatening
• Patient Age: 53 YR