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

Model Number	N/A
Medical Device Problem Codes	Corroded (1131); Material Erosion (1214); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Joint Dislocation (2374); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
Date of Event	03/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: catalog number:00801803604, lot number: 62178302, brand name: cocr heads.Catalog number:00620006022, lot number: 62086037, brand name: f/m acet shell 60mm.Unknown stem.Unknown bearing.Multiple reports were submitted along with this report 0001822565-2022-01008.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the patient was revised due to pain, metallosis, pseudotumor and elevated metal ions approximately 8 years post implantation.Intra-operative findings included cloudy fluid, a massive solid pseudotumor with necrosis, and grade two trunnion corrosion.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.H6: proposed component code: mechanical (g04)- head.Visual examination of the provided pictures identified black debris on the surface of the head.Products are covered in bio-debris.No pictures were provided of the stem reported event was unable to be confirmed.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.Root cause could not be determined as the necessary information to adequately investigate the reported event was not 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.
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.Multiple reports were submitted along with this report 0001822565-2022-02036.
Event or Problem Description
It was reported that the patient was revised due to pain, multiple dislocations, metallosis, pseudotumor and elevated metal ions approximately 8 years post implantation.During the revision, mild wear was found to the trunnion was found, leading to chronic instability.Damage was noted in much of the abductor musculature, proximal portion the vastus lateralis, a portion of the short external rotator muscles, and necrotic tissue to the gluteus minimus.It was also noted that there was grey-tinged fluid in the hip joint, but patient was negative for infection.The stem was left intact, and all other components were replaced with a mixed manufacture combination.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.The following sections were updated/corrected updated: d4(udi); g3; h2; h6 d4 (udi): remove udi reference from the report as this device was manufactured prior to the requirement and publication of the udi requirement.Visual examination of the additional provided pictures identified the explanted head, shell, liner, and screw, all covered in bio-debris.The head shows black debris and damage is noted to the liner from explant.No further evaluation can be made from the provided pictures, and pictures were not provided of the stem.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: a revision was performed as the patient was experiencing chronic instability with 3 dislocations, trunnionosis, and elevated metal ions.During the revision, extensive tissue damage was encountered with necrotic tissues from metallosis.Black debris was noted between the head and stem.The surgery was completed with zimmer and depuy products, and a drill bit broke deep within the bone but was not retrieved.The drill bit was likely a depuy product.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event for the liner and stem.Root cause 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 additional event information to report at this time.

• Brand Name: FEMORAL HEAD STERILE
• 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: 14103172
• Report Number: 0002648920-2022-00084
• Device Sequence Number: 14649814
• Product Code: LPH
• UDI-Device Identifier: 00889024144743
• UDI-Public: (01)00889024144743(17)220922(10)62178302
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K953337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/09/2022

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: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 00801803604
• Device Lot Number: 62178302
• 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: 03/18/2022
• Supplement Date Received by Manufacturer: 05/06/2022; 06/22/2022; 10/19/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 05/20/2022; 07/15/2022; 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2012
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male