MAUDE Adverse Event Report: ZIMMER GMBH ANATOMICAL SHOULDER, HUMERAL STEM, UNCEMENTED, 9; AMATOMICAL SHOULDER WITH REMOVABLE HEAD

Model Number N/A

Device Problems Fracture (1260); Naturally Worn (2988)

Patient Problems Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Reaction (2414)

Event Date 06/26/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products and therapy date detail of product: item number: 0104250045, item name: anatomical shoulder bigliani/flatow, adapter, 45, lot # 2642436; item number: 00111314001, item name palacos rg 1x40 single, lot # 75184318; item number: 00430205224 item name: offset modular humeral head 24 mm head height 52 mm spherical head diameter, lot # 62009890; item number; 00432605200, item name: trabecular metalâ?¢ glenoid component 52 mm articular surface use with blue instruments & blue humeral head, lot # 62220037.The manufacturer did not receive x-rays but received other source documents for review.The manufacturer did not receive the device for investigation.The device history records were reviewed and found to be conforming.Attempts to obtain additional information have been made; however, no more is 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.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

Clinical study reported that patient underwent revision surgery due to implant fracture, pain, osteolysis due to implant (poly) wear with debris, metallosis and limited range of motion.During the revision surgery cultures were taken which were tested positive for infection.Patient was placed on iv antibiotic therapy and remains implanted.

Manufacturer Narrative

This follow-up report is being filled to relay investigation result.Additional and corrected information are filled in the following fields: additional: h2 - h6.Correction: b4 - g4 - g7 - h10.Trend analysis: no trend has been identified.Event description: it was reported that patient underwent an initial implant surgery on (b)(6) 2012 and underwent a revision surgery on (b)(6) 2019 due to glenoid component fracture, pain,osteolysis due to implant (poly) wear with debris, metallosis and limited range of motion.Stem was left in place.During the revision surgery cultures were taken which were tested positive for infection.Patient was placed on iv antibiotic theraphy and reamains implanted.Review of received data: revision op notes and crf notes dated for (b)(6) 2019 were reviewed by hcp and identified: left shoulder pain; limited/decreased rom; failed anatomic total shoulder arthroplasty w/glenoid component wear & fracture; 6 months of symptoms prior to surgery; deltopectoral surgical approach; deltoid found normal, rotator cuff intact, notes biceps absent; subscapularis tendon intact, but thin; abundant metallosis/staining of soft tissue; humerus bone quality weak; proximal humerus osteolysis -states due to polyethylene-induced inflammation; glenoid bone quality normal, wear pattern c2, deepest bone defect inferior, glenoid erosion severe ¿ bone graft placed; glenoid component found fractured; scar tissue and thickening of capsule; general anesthesia and regional block; under head, gray play-doh-like wear debris and synovitis, culture sent; abundant poly wear; notes trabecular metal keel was ingrown in the glenoid bone, after explant left bone defect; no complications; (b)(6) 2019 discharged w/ outpatient therapy, home exercise; placed on aspirin, percocet and senokot-s; intraoperative cultures taken during revision on (b)(6) 2019 positive for propiobacterium acnes rare; picc line placed; antibiotic vancomycin given; imaging indicates good placement post procedure; seeing infection disease for treatment; notes surgical incision is healing well w/out redness or drainage.Device analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: all involved devices are intended for treatment.Dhr review: the quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Sterilization certificate: the sterilization certificate were reviewed.Conclusion: the investigation results did not identify a non-conformance or a complaint out of box (coob).The quality records show that all specified characteristics (material, dimensions, surface, etc.) have met the specifications valid at the time of production.Neither x-rays nor the explant or photos of the explant were received; therefore the condition of the components is unknown.Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs.High impact), and relevant medical history are unknown.Adherence to rehabilitation protocol is unknown.The gamma sterilization specification of the device certifies the suitability of sterilization.The irradiation certificate of the affected lot has been reviewed and was found to be according to specification.Therefore, it can be excluded that an unsterile device caused the infection.Moreover, no trend on infection has been observed for this part or lot numbers.Therefore, it is highly unlikely that a disadvantageous product design favored or contributed to the infection.As the infection has been detected after the products have been implanted for more than 6 years, it is highly unlikely that the implants caused or contributed to the infection.However, based on the available information, we were not able to identify an exact root cause for this issue.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

Please refer to report 0009613350-2019-00547.

• Brand Name: ANATOMICAL SHOULDER, HUMERAL STEM, UNCEMENTED, 9
• Type of Device: AMATOMICAL SHOULDER WITH REMOVABLE HEAD
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 8944757
• MDR Text Key: 155965821
• Report Number: 0009613350-2019-00547
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 00889024285576
• UDI-Public: 00889024285576
• Combination Product (y/n): N
• PMA/PMN Number: K030259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2017
• Device Model Number: N/A
• Device Catalogue Number: 01.04201.092
• Device Lot Number: 2658024
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 91