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

Model Number	36
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision of bioball head and neck implants with bioball 7.5 large sleeve and 36 ceramic bioball head.Paragon stem remains in situ.Patient is a (b)(6) female with below average activity levels.
Additional Manufacturer Narrative
The products were not returned and no products of the belonging batches were on stock.On request the further involved articles were determined.No further patient information was provided.During investigation, it was clarified, that the bioball head geometry is determined by a standard and a negative impact or cause for this complaint can be excluded.Furthermore, it was cleared, that the adapter/neck combination was choosen correct so that a possible impingement can be excluded, too.It was reported by the distributor, that the patient was involved in more previous revisions with two of them including merete articles.For both cases a product or production error was not identified.The patient revision history shows, that an adapter/neck change in size and/or type was performed with each revision: from standard s to standard m to offset l and now to standard l, which indicates a complicated and changing patient constitution (e.G.Regarding soft tissue tension).A possibly wrong choice of adapter/neck, especially from offset back to standard with the last revision and the choice of already revised size m before, is noticeable.A dhr review was performed brought up no deviations.The belonging risk analysis covers the scenario of luxation and corresponding measures were derived (tests, design, process controls, ifu/labelling).A customers feedback was provided about the known side-effect of luxation/dislocation and an information of awareness regarding the adapter choice and the use of trial components.It was double-checked and confirmed that the distributor/customer is in possession of trial component trays.Please note: this report is filed with the fda due to an adverse event experienced with a device that is also placed on the market in the usa, however, this event occurred outside of the usa.

• 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
• Manufacturer Contact: paul münch ; alt-lankwitz 102; berlin, berlin 12247 ; GM 12247
• MDR Report Key: 12916531
• Report Number: 3002949614-2021-00005
• Device Sequence Number: 20231195
• Product Code: LZO
• UDI-Device Identifier: 04048266025470
• UDI-Public: (01)04048266025470(17)250506(10)7011467309/05
• 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: 2020
• 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): 12/01/2021

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: 05/06/2025
• Device Model Number: 36
• Device Catalogue Number: HM50036
• Device Lot Number: 7011467309/05
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female