MAUDE Adverse Event Report: ZIMMER BIOMET, INC. COMP RVRS SHDR GLEN BSPLT +HA; PROSTHESIS, SHOULDER

Catalog Number 115330

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

Patient Problems Wound Dehiscence (1154); Fatigue (1849); Fever (1858); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Swelling (2091); Weakness (2145); Sweating (2444)

Event Date 11/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Product code: phx.Concomitant medical products: comp rvrs shdr glen bsplt +ha cat# 115330 lot# 247040.Comp rvrs shldr glnsp std 36mm cat# 115310 lot# 988470.Versa-dial/comp ti std taper pr adaptor cat# 118001 lot# 384560.Arcom xl 44-36 std hmrl brng cat# xl-115363 lot# 386590.Comp lk scr 3.5hex 4.75x15 st cat# 180550 lot#ni.Comp lk scr 3.5hex 4.75x30 st cat# 180553 lot#ni.Comp.Rev shldr 9 in steinmann cat# 405800 lot#442310.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 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-03720, 0001825034-2020-03721, 0001825034-2020-03722, 0001825034-2020-03723, 0001825034-2020-03724.

Event Description

It was reported a patient underwent an initial left total shoulder arthroplasty.Subsequently, the patient was started on antibiotics approximately 2 weeks later for possible infection.The patient continued with antibiotics and had an irrigation and debridement procedure approximately 5 months post op.The patient was again started on antibiotics for infection approximately 2 years post op.The patient had an abscess drained and eventual product removal and placement of a cement antibiotic spacer approximately 35 months post op.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

D4: (b)(4).The reported event of deep infection <90 days occurred post implantation.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.This patient has a history of leukopenia which can inhibit the body's ability to fight infection due to low white blood cell count.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted product is not identified as the source or contributing to the reported infection and is considered not reportable.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: two weeks post-op appointment noted small amount of clear drainage from the bottom of the incision.Redness around the incision.Began a course of antibiotics.Patient continued to experience drainage and had small opening near the bottom of the incision seven days later.Surgeon discussed possibly washing out the seroma and possibility of having a drain placed.Three weeks post-op, surgeon noted incision continues to ooze.Surgeon thinks possible reaction to the vicryl sutures.Three months post-op surgeon noted the shoulder was draining and a small blister like area opened up.Cultures grew enterobacter.Continued antibiotics.At the end of the month, the incision area opened up subcutaneously.Five months post-op patient had an i&d and washout.In (b)(6) 2017 surgeon felt wound was completely healed.In (b)(6) 2018, patient called to say his shoulder was infected.Shoulder aspirated and cultures sent.Started on antibiotics (amoxicillin and bactrim).Cultures showed enterobacter cloacal.Added cipro when amoxicillin finished.In (b)(6) 2018, patient called stating the infection was back again.The surgeon observed a 3cm swelling over mid-incision and diagnosed it as an apparent abscess.Abscess drained and cultures sent.Patient referred to infectious disease specialist.Continued cipro/bactim regime that was previously ordered.Patient underwent surgery for implant removal and abx spacer placement.In november 2018, pt complained of bleeding which was resolved; however, now has leg pain.Therefore, patient was started on gabapentin.On (b)(6) 2018, patient presented to er with worsening fatigue, chronic leg pain, fever, chills, decreased appetite, and sweating.Patient became lethargic with difficulty walking and slurred speech.Patient diagnosed with leukopenia, and suffering redness at the bottom of the incision.Patient ordered to continue receiving i.V.Antibiotics.On (b)(6) 2018, patient presented to er again, complaining of weakness, fever, shaking, left foot drop, mild erythema to the left should wound, disoriented and not making sense.Patient had picc line d/c and placement of a central line.Patient was diagnosed with septic shock.From (b)(6) 2019, completed i.V.Antibiotics.Still complaining of leg pain and foot drop.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A definitive root cause cannot 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 Description

No further event information is available at the time of this report.

• Brand Name: COMP RVRS SHDR GLEN BSPLT +HA
• Type of Device: PROSTHESIS, SHOULDER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10638163
• MDR Text Key: 210208951
• Report Number: 0001825034-2020-03719
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• PMA/PMN Number: K080642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 115330
• Device Lot Number: 247040
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Other; Required Intervention