MAUDE Adverse Event Report: ZIMMER BIOMET, INC. SHELL WITH CLUSTER HOLES POROUS 56 MM O.D. SIZE KK FOR USE WITH KK LINERS; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: femoral stem cat#00771101220 lot#61919534.Shell with cluster holes porous 56 mm o.D.Size kk cat#00875705601 lot#61972929.Bone scr 6.5x40 self-tap cat#00625006540 lot#61724549.Neutral liner 36 mm i.D.Size kk cat#00875101236 lot#61934209.Reported event was confirmed by review of medical records.Operative notes were provided and reviewed by a health care professional.The patient underwent an initial r tha on (b)(6) 2012 due to oa; no intraoperative complications were identified.Patient was revised (b)(6) 2020 due to altr, corrosion, necrosis, osteolysis and subluxation.During procedure corrosion was noted at the head neck junction with notable altr.Substantial tissue necrosis involving the posterior capsule.The femoral component was well fixed with lysis around the upper portion that was debrided.The acetabular component was placed in slight anteversion; with minor internal rotation of the hip, the head was beginning to subluxate.Patient had a history of subluxation after original replacement.Shell was removed with minimal bone loss.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause for the corrosion related issues cannot be determined.It was identified that the shell was slightly anteverted; this is what caused the reported subluxation.A definitive root cause to the anteverted shell could not be determined.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-03205.0002648920-2020-00407.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
It was reported the patient underwent a revision procedure approximately 8 years post implantation due to altr, in-vivo corrosion, necrosis, osteolysis, and subluxation.No further event information available at the time of this report.

• Brand Name: SHELL WITH CLUSTER HOLES POROUS 56 MM O.D. SIZE KK FOR USE WITH KK LINERS
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10934194
• Report Number: 0001822565-2020-03890
• Device Sequence Number: 19072518
• Product Code: JDI
• UDI-Device Identifier: 00889024151437
• UDI-Public: (01)00889024151437
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2020

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: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: 00875705601
• Device Lot Number: 61972929
• 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: 08/21/2020
• Initial Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention