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	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient received a hip revision on (b)(6) 2021.Due to infection the patient received a second revision on (b)(6) 2021.The surgeon performed a washout and revised the right hip.The bioball delta keramik-steckkopf ø36 mm, the bioball 7,5 ° offset adapter, 12/14, 2xl and the global cup poly liner lipped were explanted.The product was not returned.The batch review - especially for the sterilization records - was performed and brought up no deviations.Also no similar complaint with similar batch numbers has been reported yet.A possible root-cause by transport damage is excluded because of existing transport validation and further monitoring and inspection measures by the distribution partner, who reported no packaging damage.The risk of infection is a known risk with the procedure and covered by the risk analysis and corresponding information is given in the belonging accompanying product information.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 hip due to infection on (b)(6) 2021.This is the second revision due to infection for this patient.The first revision occurred on (b)(6) 2021.The surgeon performed a washout and revised the right hip, global liner, merete femoral head and merete femoral neck were explanted.The surgeon removed the cup screws to see if there was infection behind the cup, then performed a washout and implanted new screws.

• 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: 11264608
• Report Number: 3002949614-2021-00001
• Device Sequence Number: 1284035
• 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): 02/02/2021

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: 03/08/2023
• 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: 01/11/2021
• Initial Report FDA Received Date: 02/02/2021
• 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