MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FEMORAL STEM PRESS-FIT COLLARLESS STEM CEMENTLESS; PROSTHESIS, HIP

Catalog Number	00786401320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Hematoma (1884); Unspecified Infection (1930); Post Operative Wound Infection (2446)
Date of Event	12/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event: 0001825034-2023-00200, 0001825034-2023-00201, 0001822565-2023-00267, and 0001822565-2023-00268.Concomitant medical products: product id: bone scr 6.5x30 self-tap, cat #: 00625006530, lot #: j7352161; product id: bone scr 6.5x30 self-tap, cat #: 00625006530, lot #: j7352156; product id: biolox⮠delta, ceramic femoral head, s, 㸠32/-3.5, taper 12/14, cat #: 00877503201, lot#: 3069804; product id: g7 osseoti multihole 50mm d, cat #: 110010263, lot #: 65506475; product id: g7 longevity high wall 32mm d, cat #: 20123204, lot #: 65462155.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported the patient underwent a left hip revision approximately one month post implantation due to a post-op hematoma and draining sinus.This required an incision, drainage, antibiotics and joint debridement.Concluding this procedure, an unspecified infection was noted.It was reported that no further information is available.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00267-1, 0001822565-2023-00268-1.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities/risk factors.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, implanted products are not identified as the source or contributing to the reported infection.A hematoma is a mass of clotted blood that forms in a tissue, organ, or body space.A hematoma can be associated with pain, swelling, ecchymosis, serosanguinous or bloody drainage after a recent surgical procedure or trauma and can predispose the patient to infection.The development of a postoperative hematoma can be correlated with the surgical procedure and perioperative anticoagulation therapy prescribed to prevent thrombus formation.Most hematomas resolve on their own, without surgical intervention, while some do not.Larger hematomas may need to be surgically evacuated in order to resolve.As timeframes of onset differ due to individual contributing factors, a specific timeframe of expected occurrence cannot be established.
Event or Problem Description
It was reported the patient underwent a left hip revision approximately one month post implantation due to a post-op hematoma and draining sinus.This required an incision, drainage, antibiotics and joint debridement.Concluding this procedure, an unspecified infection was noted.The patient was treated with iv antibiotics.Approximately a month later the patient experience continued wound drainage and signs of an infection.The patient was covid positive and underwent a second irrigation and debridement along with replacement of the head and liner.Cultures from this revision surgery were positive for infection and patient continued iv antibiotics along with follow up care from an infectious disease specialist.

• Brand Name: FEMORAL STEM PRESS-FIT COLLARLESS STEM CEMENTLESS
• Common Device Name: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16284948
• Report Number: 0001822565-2023-00269
• Device Sequence Number: 11982211
• Product Code: JDI
• UDI-Device Identifier: 00889024139268
• UDI-Public: (01)00889024139268(10)65603489(17)321010
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K200823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 00786401320
• Device Lot Number: 65603489
• 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: 01/11/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 02/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Race: White