MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 36MM I.D. SIZE OO ELEVATED RIM LINER USE WITH 64MM O.D. SIZE OO SHELL; PROSTHESIS, HIP

Catalog Number 00875201636

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Hematoma (1884); Impaired Healing (2378)

Event Date 08/07/2019

Event Type  Injury  

Event Description

It was reported that patient underwent total left hip arthroplasty approximately 4 years ago.Subsequently, the patient underwent two separate revisions of the acetabular and femoral components due to loosening.Approximately three weeks after the second revision, the patient experienced a postop hematoma which was surgically debrided without complication.Intraop cultures grew staphylococcus epidermis indicating a superficial infection.The debridement did not extend into the joint, and no product was exchanged.After changing the postop antibiotics, the patient healed without further complications.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted part # unknown / unk 36+10.5 femoral head/ lot # unknown.Part # unknown / unk tm 64mm cup/ lot # unknown.Part #unknown / unk screws/ lot # unknown/ quantity 7.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-00225, 0001822565-2022-00226, 0001822565-2022-00230.

Event Description

No additional event information to report at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d1; d2; d4 (catalog number); g3; g4; h2.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D10: 00875706402 ¿ continuum shell ¿ unknown lot, 00625006520 ¿ bone screw ¿ unknown lot, 00625006525 ¿ bone screw ¿ unknown lot, 00625006535 ¿ bone screw ¿ unknown lot, 00625006535 ¿ bone screw ¿ unknown lot, 00625006530 ¿ bone screw ¿ unknown lot, 00625006520 ¿ bone screw ¿ unknown lot, 00625006540 ¿ bone screw ¿ unknown lot.It was reported that a patient experienced wound dehiscence and hematoma from that was debrided and repaired approximately three weeks post hip revision.The cultures from the procedure were positive for staph epidermis which is a common skin flora.It is expected that a wound heals in stages and should be of normal appearance related to the timeframe since the incision was made.A surgical wound should be well approximated without redness, warmth, swelling and/or purulent drainage for the duration of its healing.The expression wound concerns or non-healing wound would imply that the appearance of the wound deviates from what a surgical wound should appear as.It may be red, have drainage, additional pain, warmth and swelling as well as healing time may be delayed.This deviation signifies an alteration in the wound healing process.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.The development of a postoperative hematoma after a procedure can be correlated with the surgical procedure and perioperative anticoagulation therapy to prevent dvt (prophylaxis).Patients may be at increased risk for developing hematomas if they have received fresh-frozen plasma, vitamin k, or hormonal therapy as well.Most hematomas resolve on their own, without surgical intervention, while some others 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.The presence of a hematoma increases patient risk for infection and wound complications.At the time of positive cultures, the femoral head had been in place for approximately three weeks, and part and lot are known.Superficial infections are considered a procedure related complication as no device has been reported as revised.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.During the investigation process a review of the sterile certifications were reviewed and found to be conforming with no applicable deviations, further eliminating the implanted devices as a potential source for the reported infection.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.As device has not been indicated as revised and there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted products are not identified as the source or contributing to the reported infection.All other subforms/implants had been in place for approximately 8 months and would not be considered as causing or contributing to the recent superficial infection.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 Description

No additional event information to report at this time.

• Brand Name: 36MM I.D. SIZE OO ELEVATED RIM LINER USE WITH 64MM O.D. SIZE OO SHELL
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 13391612
• MDR Text Key: 284676949
• Report Number: 0001822565-2022-00229
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 00875201636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10; SEE H10
• Patient Outcome(s): Hospitalization; Other
• Patient Sex: Male
• Patient Weight: 114 KG