MAUDE Adverse Event Report: ZIMMER GMBH BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14; PROSTHETIC, HIP

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a revision procedure 6 years and 9 months post implantation due to the liner fracturing at the locking ring.There was metal transfer onto the ceramic femoral head and evidence that the head had been rubbing on the interior of the acetabular shell.Ambulation was limited by pain.There is no additional information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10: liner standard 3.5 mm offset 36 mm i.D.For use with 50/52/54 mm o.D.Shells item #00630505036 lot #63353645.Shell porous with cluster holes 50 mm o.D.Item # 00620005022 lot #63283875.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that the patient had a revision procedure 6 years and 9 months post implantation due to the liner fracturing at the locking ring.There was metal transfer onto the ceramic femoral head and evidence that the head had been rubbing on the interior of the acetabular shell.Ambulation was limited by pain.However, upon further review it was found that this device is not contributory to the reported event.
Additional Manufacturer Narrative
Upon further review of this complaint, it was determined that this product did not contribute to the reported event and this report will be considered voided.The product contributing to the reported event was reported on (b)(4), 0001822565-2023-03621.

• Brand Name: BIOLOX® DELTA, CERAMIC FEMORAL HEAD, M, ø 36/0, TAPER 12/14
• Common Device Name: PROSTHETIC, HIP
• 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: 18343507
• Report Number: 0009613350-2023-00696
• Device Sequence Number: 12461837
• Product Code: LZO
• UDI-Device Identifier: 00889024430365
• UDI-Public: (01)00889024430365(17)260430(10)2844194
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K192416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 00877503602
• Device Lot Number: 2844194
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2016
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 72 KG