MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. FEMORAL HEAD; PROSTHESIS HIP

Catalog Number	00801803602
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Host-Tissue Reaction (1297); Necrosis (1971); Pain (1994); Loss of Range of Motion (2032); Local Reaction (2035); Tissue Damage (2104); Joint Dislocation (2374); Numbness (2415); Ambulation or Postural Difficulties (2544); Muscle/Tendon Damage (4532)
Date of Event	12/31/2019
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 product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical devices: part# 65771100620/ femoral stem/ lot# 60418105; part# 00630505036/ liner/ lot # 62175103; part# 00620205022/ shell/ lot # 62151566; part# 00625006540/ bone screw/ 62211435.Event was initially reported on 0001822565-2020-04245.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 -2021 -00287, 0001822565 -2021 -00293.
Event or Problem Description
It was reported patient underwent a right hip closed reduction approximately 7 years post implantation due to dislocation and was subsequently revised 5 months later due to pain, elevation metal ion levels, adverse location tissue reaction, and corrosion.The head and liner were revised.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Medical records were provided and reviewed by a healthcare professional.The following findings were noted.Patient underwent an initial.Patient experienced a dislocation and underwent a closed reduction.Patient was then revised again due to pain, elevated metal ions, altr and corrosion.Dislocation may have been linked to the altr as the joint was lax due to the tissue damage.Turbid fluid, synovial tissue was hypertrophic, and debrided, necrotic debris with pseudotumor.There was a loss of one third of the abductors.Black precipitate was found on the trunnion after removing the head.No damage to locking ring.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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 further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Updated: b5, d9, g3, h2, h3, h6.
Event or Problem Description
It was reported patient underwent a left hip closed reduction approximately 7 years post implantation due to dislocation and was subsequently revised 5 months later due to pain, elevation metal ion levels, adverse location tissue reaction, and corrosion.The head and liner were revised.
Event or Problem Description
No additional event information to report at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.Proposed component code: mechanical g (04)- head.Visual examination of the returned product identified dark debris and a circumferential groove pattern is seen on surface of the conical taper.The poly liner was returned with the rim feature removed.Damage is seen in the inner surface and backside.The stem remains implanted.The head was submitted for further analysis and found to have ¿damage over the majority (>50%) of the surface with severe corrosion attack and abundant corrosion debris." root cause unchanged.This complaint was confirmed based on the returned device and medical records.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.

• Brand Name: FEMORAL HEAD
• 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: 11269635
• Report Number: 0002648920-2021-00017
• Device Sequence Number: 4502444
• Product Code: LPH
• UDI-Device Identifier: 00889024144729
• UDI-Public: (01)00889024144729(17)221017(10)62199447
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/11/2023

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: 10/17/2022
• Device Catalogue Number: 00801803602
• Device Lot Number: 62199447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 04/20/2021; 06/08/2023; 08/03/2023
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 04/22/2021; 06/28/2023; 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2012
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Weight: 78 KG