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

Model Number	N/A
Medical Device Problem Code	Material Erosion (1214)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2021 - 00241.
Event or Problem Description
It was reported a patient underwent a hip revision due to trunionosis and elevated chromium levels.No further event information available at the time of this report.
Additional Manufacturer Narrative
Reported event was confirmed due to the review of medical records.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed.Labs done show elevated cobalt levels.A revision was performed due to with metallosis within the joint and the posterior capsule ruptured.Corrosion found on the trunnion and within femoral head.The trunnion was cleaned and new zimmer head and liner implanted without complication.Device history record (dhr) was reviewed and no discrepancies were found.Root cause remains unchanged.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 information.D10: m/l taper femoral stem (00-7711-013-00, 63321324).Trilogy acetabular shell (00-6200-058-22, 63357261).Trilogy acetabular liner (00-6305-058-36, 63344357).
Event or Problem Description
It was reported the patient underwent a left hip revision approximately 4 years pot implantation due to pain and was found to have elevated cobalt levels.Surgeon reported corrosion, tissue damage and scar tissue.No additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: h6 proposed component code: mechanical (g04)- head.Visual examination of the returned product identified light scuffing on the outer radius and one larger scratch.Debris is present inside the taper of the head.The stem remains implanted.The head was submitted for further analysis.Analysis determined a consensus modified goldberg score of 3.A score of 3 corresponds to fretting on more than a third of the surface and/or aggressive local corrosion attack with corrosion debris review of complaint history identified additional similar complaints for the head, no additional complaints for the stem, and no additional complaints for the reported part and lot combinations.Complaints are monitored through monthly complaint review in order to identify potential adverse trends.Root cause unchanged.This complaint was confirmed based on the returned device and medical record.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
There is no update to the prior event description provided.

• 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: 11824534
• Report Number: 0002648920-2021-00124
• Device Sequence Number: 19875550
• Product Code: LPH
• UDI-Device Identifier: 00889024144712
• UDI-Public: (01)00889024144712(17)260731(10)63415130
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,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: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: 00801803601
• Device Lot Number: 63415130
• 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: 04/28/2021
• Supplement Date Received by Manufacturer: 09/22/2021; 11/10/2021; 01/09/2024
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 10/20/2021; 11/17/2021; 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2016
• 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 NARRATIVE.; UNKNOWN CUP.; UNKNOWN LINER.; UNKNOWN STEM.; UNKNOWN CUP; UNKNOWN LINER; UNKNOWN STEM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male