MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 32MM I.D. SIZE KK WITH CONSTRAINING RING CONSTRAINED LINER; PROSTHESIS, HIP

Catalog Number	00875801232
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Pain (1994); Joint Dislocation (2374); Metal Related Pathology (4530)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-02859.D10: cat #: 00784804400 / modular neck d 12/14 neck taper use with +0 heads only / lot #: 63789786.Cat #: 00877503202 / biolox⮠delta, ceramic femoral head, m, 㸠32/0, taper 12/14 / lot #: 2919486.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 a patient underwent a hip revision approximately five years post implantation due to pain and a dislocation.During the revision, it was noted that the liner and ring were intact and that there was significant metal debris (black tissue) found in the wound site.Upon examination of the anterior neck, it was discovered that this item was grinding on the acetabular cup.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4; b5; d9; g3; h2; h3; h4; h6 visual examination of the returned product identified constraining ring shows deformation damage to the raised area from the modular neck articulating against the surface.Nicks and scratches are noted around the circumference.Constrained liner was not returned with the constraining ring for evaluation.The provided picture shows the neck within the hip, with black stained tissue surrounding it.However, the neck impingement and subsequent tissue damage is secondary to the dislocation.The complaint cannot be confirmed.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No additional event information to report at that time.

• Brand Name: 32MM I.D. SIZE KK WITH CONSTRAINING RING CONSTRAINED LINER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17957828
• Report Number: 0001822565-2023-02858
• Device Sequence Number: 20613027
• Product Code: JDI
• UDI-Device Identifier: 00889024151857
• UDI-Public: (01)00889024151857(17)221031(10)63830633
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 00875801232
• Device Lot Number: 63830633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 77 KG