MAUDE Adverse Event Report: ZIMMER GMBH CERASUL®, HEAD, S, ø 28/-3.5, TAPER 12/14; HIP IMPLANT

Model Number N/A

Device Problem Fracture (1260)

Patient Problems Fall (1848); Failure of Implant (1924); Pain (1994); Osteolysis (2377); Metal Related Pathology (4530)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: unknown liner- unknown lot and item #.G2: foreign: germany.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 Description

It was reported that a patient had a revision surgery due to fracture of the ceramic head, and there was a noticeable indentation in the prosthetic neck.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected d10: ref.4246 lot 2305876 allofit shell ; ref.0100010610 lot 2301765 cerasul alpha insert ; ref.290039125 lot 2305955 cls stem 135° uncemented 12.5 taper 12/14.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 Description

It was reported that a patient had a revision surgery due to a fall.During the revision, the inlay showed partial destruction and there were massive black deposits noted corresponding to severe metallosis in the capsule tissue and the adjacent soft tissue.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records and raw material certificates confirmed no abnormalities or deviations.The reported products were reviewed for compatibility with no issues noted.Review of the complaint histories found no additional related complaints for these items and the reported part and lot combinations.Based on the anamnesis provided and the reported fall event, it is likely that the fall event potentially caused or contributed to the reported event of femoral head and liner fracture.However, with the available information, a definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2024-00058.

Event Description

It was reported that a patient had a revision surgery due to fracture of the ceramic head, and there was a noticeable indentation in the prosthetic neck.During the revision over 17 years post-implantation, the inlay showed partial destruction and there were massive black deposits noted corresponding to severe metallosis in the capsule tissue and the adjacent soft tissue.Due diligence has been completed for this complaint; to date no additional information or product has been received.

• Brand Name: CERASUL®, HEAD, S, ø 28/-3.5, TAPER 12/14
• Type of Device: HIP IMPLANT
• 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: 18343505
• MDR Text Key: 330662937
• Report Number: 0009613350-2023-00697
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 00889024536791
• UDI-Public: (01)00889024536791(17)100715(10)2278089
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K181171
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/15/2010
• Device Model Number: N/A
• Device Catalogue Number: 4070101
• Device Lot Number: 2278089
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2005
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 105 KG