MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-42; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Model Number N/A

Device Problems Fracture (1260); Biocompatibility (2886)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Implant Pain (4561)

Event Date 11/12/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: base plate 25 mm post length +2 mm lateral offset uncemented; item# 00434902502; lot# 63347285.The manufacturer did not receive x-rays for review.Other source documents were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Additional information has been requested and is currently not available.A cause for this specific event cannot be ascertained from the information provided.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).

Event Description

Patient was implanted on left side and underwent revision surgery due to implant fracture, pain and possible deep infection.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Event description: it was reported on a maude report that a patient underwent a zimmer reverse shoulder arthroplasty on (b)(6)2016.Subsequently, the patient underwent a revision on (b)(6)2018 due to pain and by the patient reported glenoid fracture.The revision consisted of an arthroplasty resection with placement of a cement spacer.2.Review of received data: - due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.- review of available medical records can be summarized as follows: mayo clinic (mr (b)(6) 2018.Pdf): - admission date: (b)(6) 2018.- discharge date: (b)(6) 2018.- diagnosis: pain shoulder left.- procedure performed on (b)(6) 2018: resection left total shoulder arthroplasty components with antibiotic spacer placement - discharge summary: the patient was taken to the operating room for the above noted procedure.Patient did well and was taken to the post anesthesia care unit in stable condition and eventually transferred to the general orthopedic floor.Infectious diseases were consulted and the patient received antibiotics per their recommendations.Pain service was consulted for assistance with pain management.Pain was initially controlled with iv analgesia.Prior to dismissal, pain was well controlled with oral medications.By the time of dismissal, preoperative bowel and bladder function returned to normal and the patient was tolerating a regular diet.Physical therapy was consulted for mobilization and to help develop a plan for home care.The patient was dismissed in stable condition.- bacterial test results: pending at discharge.- progress notes from (b)(6)2018: staph epi is from the aerobic plate and is <20c fu.Another organism <20 c fu from anaerobic plate has not been identified yet.I asked the lab to identify it.Patient is doing well post-operatively.Pain better controlled.- assessment / plan.1.Painful left shoulder arthroplasty, multiply revised, indeterminate for ongoing infection, previously treated with prolonged empiric courses of therapy, now status post resection of shoulder arthroplasty and placement of antibiotic cement spacer on (b)(6)2018.2.History of primary shoulder arthroplasty in 2013 with outside diagnosis with infection with at least 1 culture growing propionibacterium acnes and coag-negative staph 3.Treated with 2-stage exchange procedure (resection (b)(6) 2016, reimplantation (b)(6) 2016).4.History of vancomycin, doxy and daptomycin allergy/intolerance 5.Previous history of port-associated dvt - discussion: the female patient is a 57-year-old female who has been admitted to the hospital for resection arthroplasty of left shoulder.She underwent the procedure on (b)(6)2018.She has shoulder pain, warmth on palpation, acute inflammation on pathology and elevated inflammatory markers in the absence of obvious infection or purulence or hardware loosening intra-operatively and negative cultures including broad range pcr in the past.She has symptomatically felt better on antibiotics in the past and her symptoms have worsened without it, justifying antibiotic use.The etiology of her pain remains unknown.One of the cultures is growing what appears to be cons.This is <20c fu which is considered to be not significant.Since we have had trouble identifying an infection in the past, we have asked micro lab to speciate this organism.However, it will be hard to determine the significance of this since this could be a contaminant.In the past she has tolerated ertapenem and this has helped her with pain and warmth.The use of antibiotic is primarily because of personal history of improvement.There is no confirmed evidence of infection.- precautions: non-weight bearing left upper extremity, daily physical therapy - final pathology: synovium, left shoulder, biopsy: focal acute inflammation - bacteria cult, aerobe/anaerobe+susc: no growth after 14 days of incubation.Staphylococcus epidermidis < 20 cfu/10 ml, c utibac terium ac nes < 20 cfu/10 ml - surgical report from 12 nov 2018: diagnosis: painful left reverse shoulder arthroplasty, possible deep infection procedure: skin incision.Exposure was difficult secondary to patient¿s multiple prior surgeries.The polyethylene of the humeral component was removed.Humeral component was well fixed.Osteotomy was performed to remove the component.An osteotome was used in order to remove the glenoid sphere.Removal of the locking caps as well as the screws used to fixate the glenoid.All parts sent for ultrasound studies.Baseplate was well fixed and was difficult to remove.5 samples of tissue cultures.Biomet cement spacer kit was used with stryker bone cement and antibiotics, spacer placed in the humeral canal.- ct left shoulder wo contrast, collected on (b)(6) 2019 findings: polymethylmethacrylate shoulder arthroplasty spacer is present in the humerus.The humeral head articular surface is pointed nearly completely anteriorly, subluxed out of the glenoid itself.There is a periprosthetic fracture of the proximal humerus with some callus formation.There is a comminuted fracture of the glenoid with significant bony loss of the glenoid articular surface.There is a remaining metallic surgical fragment in the inferior glenoid/scapular measuring 17 mm in size.Along the posterior and inferior margin of this metallic fragment there is a large fracture which is mostly vertically oriented in an oblique fashion from superolateral laterally to inferomedially through the scapular body with a maximum of 1.6 cm of displacement.This is new from the prior examination.The fracture measures approximately 10 cm in length in the craniocaudal dimension.This separates the inferolateral scapular body from the remainder of the scapula and the glenoid.Minimal fatty infiltration of the supraspinatus, subscapularis and supraspinatus muscle bellies without significant atrophy at this time.Please note, the ct images were not provided for review.- surgical report from (b)(6)2019: diagnosis: left scapula fracture, treatment: open reduction and internal fixation of left scapula fracture with bone grafting.- surgical report from (b)(6)2020: diagnosis: left shoulder possible infection, treatment: deep tissue biopsy, revision of antibiotic spacer, intraoperative findings: retained spacer, broken into multiple pieces, amenable to a humeral window, removal of this, irrigation and debridement, deep tissue biopsy.- patient data based on received medical records: b.L., female, born 17-nov-1960, 171 cm, 124 kg, bmi: 42.5 significant past medical history: right total shoulder, multiple prior surgeries (unknown dates and procedures), asthma, anxiety, depression, gerd; prior port-associated dvt, hx of vancomycin, doxy and daptomycin allergy/intolerance product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: all involved devices are intended for treatment.- product compatibility: the compatibility check was performed from www.Productcompatibility.Zimmer.Com and showed that the product combination was approved by zimmer biomet.In addition, the extremity development department confirmed the screw and baseplate compatibility.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.- sterilization certificate: the gamma sterilization specification of the device certifies the suitability of sterilization.The irradiation certificate of the affected lot numbers (2857363 and 2856360) have been reviewed and were found to be according to specifications.Conclusion: the patient underwent a zimmer reverse shoulder arthroplasty on dec 27, 2016.Subsequently, the patient underwent a revision on nov 12, 2018 due to pain and by the patient reported glenoid fracture.The revision consisted of an arthroplasty resection with placement of a cement spacer.Based on the medical records provided, there was no implant fracture of the glenoid at the revision surgery on (b)(6)2018 and the suspected deep infection could not be confirmed based on the laboratory tests.However.The pathological findings confirmed acute inflammation after the revision surgery performed on (b)(6) 2018.Furthermore, based on the surgical report of (b)(6) 2020, it can be assumed that the glenoid fracture reported by the patient refers to the fracture of the antibiotic spacer revised on (b)(6)2020.The findings of the ct scan taken on (b)(6) 2019 describe a metallic fragment of 17 mm in length.Based on the medical records received, specifically the surgical report of (b)(6) 2018, and due to the lack of radiographs, the origin of this fragment remains unknown.In addition, the ct findings describe bone loss of the glenoid vault, which may be attributed to the difficult removal of the baseplate during revision due to good osseointegration.The quality records show that all specified characteristics have met the specifications valid at the time of production.In addition, the sterilization certifications of the involved lots 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.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the investigation the reported event, deep infection and glenoid fracture, could not be confirmed.The etiology of the patient's left shoulder pain leading to the revision on (b)(6), 2018 remains unknown.The need for corrective measures is not indicated and zimmer gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-42
• Type of Device: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 11028129
• MDR Text Key: 222059155
• Report Number: 0009613350-2020-00580
• Device Sequence Number: 1
• Product Code: KWT
• UDI-Device Identifier: 00889024483057
• UDI-Public: 00889024483057
• Combination Product (y/n): N
• PMA/PMN Number: K052906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.042
• Device Lot Number: 2857363
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 124