MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD 12/14 TAPER; PROSTHESIS, HIP

Model Number	N/A
Medical Device Problem Codes	Material Erosion (1214); Unstable (1667); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Failure of Implant (1924); Necrosis (1971); Pain (1994); Scar Tissue (2060); Joint Dislocation (2374); Osteopenia/ Osteoporosis (2651); Subluxation (4525); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: part: 00875101136, lot: 61366022, liner neutral 36 mm i.D.Size jj.Part: 00875705401, lot: 31550463, shell with cluster holes porous 54 mm o.D.Size jj.Part: 00784800200, lot: 60825905, modular neck k 12/14 neck taper.Part: 00771300900, lot: 61574041, modular femoral stem press-fit size 9.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2021-00347, 0001822565-2021-02983, 0001822565-2021-02984, and 0001822565-2021-02985.
Event or Problem Description
It was reported that the patient underwent a right hip arthroplasty and subsequently was revised 9 years later due instability, subluxation and dislocation and pain.Elevated metal ions were noted.During the revision the surgeon was unable to remove neck from taper, and elected to retain stem as it was cold-welded.All other components revised.Attempts have been made and no further information has been provided.
Event or Problem Description
It was reported that the patient underwent a right hip arthroplasty revision to address pain, instability, subluxation and dislocation approximately nine (9) years post-operatively.During the revision the surgeon was unable to remove neck from taper, and elected to retain stem as it was cold-welded.All other components were revised.Initial operative notes noted no intraoperative complications.Revision operative notes identified brownish colored fluid in the joint and the hip was found to be dislocated when the capsule was opened.The head, shell and liner were removed and some significant anterior wall bone loss was noted.The neck could not be disassociated from the stem and neither were revised.No intraoperative complications relevant to the reported event were identified.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.Medical records received were received and confirmed the patient had a tendon tear, elevated metal ions as well as brownish fluid and necrosis in the joint.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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.

• Brand Name: FEMORAL HEAD 12/14 TAPER
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12627830
• Report Number: 0002648920-2021-00346
• Device Sequence Number: 16467924
• Product Code: LPH
• UDI-Device Identifier: 00889024144729
• UDI-Public: (01)00889024144729(17)201031(10)61543434
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 00801803602
• Device Lot Number: 61543434
• Was Device Available for Evaluation?: No
• 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: 09/16/2021
• Supplement Date Received by Manufacturer: 12/27/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2010
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male