MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER REVERSE, HUMERAL CUP, 0, RETRO; ANATOMICAL SHOULDER INVERSE/REVERSE

Model Number N/A

Device Problems Fracture (1260); Material Integrity Problem (2978); Patient Device Interaction Problem (4001); Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)

Patient Problems Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: unknown glenoid extremities impl win gen; item# unknown; lot# unknown.Unknown cup extremities impl win gen; item# unknown; lot# unknown.Unknown stem extremities impl win gen; item# unknown; lot# unknown.Therapy date: (b)(6) 2021.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.As no lot number was provided, the device history records could not be reviewed.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

Patient was implanted on right side and was revised due to loosening/migration of glenoid and fracture of baseplate.

Event Description

Patient was implanted on the right side and underwent a revision surgery due to loosening and migration of glenoid and fracture of baseplate.

Manufacturer Narrative

D10: medical product: anatomical shoulder humeral stem, cemented, 12, 100 mm; item# 01.04211.123; lot#: 3015699.Unk cup extremities impl win gen; catalog#: unknown; lot#: unknown.Unk stem extremities impl win gen: catalog#: unknown; lot#: unknown.Tm reverse 36mm glenosphere; item# 00-4349-036-11; lot# 64463135.Tm rvs base plt 15mm post +0; item# 00-4349-015-00; lot# 64612803.Therapy date: (b)(6) 2021.Additional information was received on apr 21, 2021.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received other source documents for review.Should additional information become available and / or the device(s) be returned for evaluation and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.Zimmer¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported that the patient received a right shoulder replacement on an unknown date in (b)(6) 2021 and underwent revision on (b)(6) 2021, due to dislocation of the glenosphere.During the revision procedure, the humeral cup could not be removed from the humeral stem, resulting in the need to revise the humeral stem as well.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.Zimmer biomet product experience report (zper): in the event section of the zper it was reported, that the humeral cup could not be disassembled from the humeral stem during revision surgery.Cement had entered the gap between the stem and the cup.The stem was explanted with the cup and a new cemented stem was implanted.X-rays: an undated x-ray image was provided and reviewed by a third party health care professional (radiologist).Apart from the findings related to the dislocation of the glenosphere, the humeral components appear to be intact and well integrated without periprosthetic lucencies.Bones are intact without fracture.Comment of the author: bone cement is visible underneath the humeral cup on the lateral side of the humeral stem.Surgical report: surgical notes were not provided.As such, no definitive statements can be made regarding the surgical technique of the implantation and revision procedures.Product evaluation: visual examination: the humeral stem with assembled humeral cup, the polyethylene insert, two screws and two locking caps were received in a sealed sterilization pouch.The colour coding of the sterilization pouch indicates a steam sterilization.Due to the steam sterilization, the polyethylene insert has an oval shape and is therefore no longer in its original condition.The anchoring surface of the insert is inconspicuous.On the articulation surface a worn zone next to the rim can be seen.In addition, there are individual dents and scratches on the surface and the rim.The screws and locking caps are inconspicuous.These had been used to anchor the glenoid baseplate and therefore are not considered to be involved in the reported event.The anchoring surface of the humeral stem is free of bone cement.There is a horizontal indentation approximately 5 mm in length on the proximal radius of the medial side.Polished areas can be found on each side of the stem¿s lateral fin.Further, there are several scratches and nicks visible on the anchoring surface of the humeral stem.Instrument marks can be seen along the anterior proximal edge of the humeral stem extending to medial adjacent to the bone cement.The posterior proximal edge adjacent to the bone cement does not show any damages.The humeral cup shows instrument marks, especially on the underside of the cup.In addition, blackish spots, possibly deriving from the use of an electrocautery tool during revision, can be found.The gap between the humeral cup and the humeral stem shows remains of bone cement.Due to the lack of patient consent, the humeral stem was not disassembled from the humeral cup.Therefore, the condition of the taper connection between the humeral stem and the humeral cup cannot be assessed.See images attached.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.Dhr review: review of the device history records identified no relevant deviations or anomalies during manufacturing.Conclusion: during revision surgery on (b)(6) 2021, the humeral cup could not be disassembled from the humeral stem, resulting in the need to revise the humeral stem as well.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).The worn zone on the articulation surface of the polyethylene insert can be considered as a result of the dislocation of the glenosphere.Bone cement was found in the gap between humeral stem and humeral cup.According to the surgical technique, the humeral components are assembled outside of the body.Subsequently, bone cement is filled into the humerus.The assembled implants are inserted into the humerus and excess cement is removed.Therefore, bone cement may enter the gap between humeral stem and humeral cup.However, the bone cement cannot enter the taper connection of the two components.As described in the surgical technique, the humeral cup is removed from the humeral stem, by sliding the humeral cup extractor between the humeral stem and the undersurface of the humeral cup.The movable part of the extractor is then firmly tapped to loosen the cup.Since bone cement was found in the gap between humeral stem and humeral cup, it is possible that the humeral cup extractor could not be placed underneath the humeral cup for removal.The instrument marks found on the proximal edge of the humeral stem indicate that attempts were made to remove the humeral cup.Based on the retrieval analysis, it can be assumed that the bone cement found in the gap between humeral stem and humeral cup may have prevented the humeral cup extractor tool from being properly placed for removal.If and to what extent an increased removal force due to bone cement between the cup and stem and / or a strong taper connection could have contributed to the reported intraoperative complication remains unknown.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

• Brand Name: ANATOMICAL SHOULDER REVERSE, HUMERAL CUP, 0, RETRO
• Type of Device: ANATOMICAL SHOULDER INVERSE/REVERSE
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11601591
• MDR Text Key: 243521947
• Report Number: 0009613350-2021-00158
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K053274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 01.04223.100
• Device Lot Number: 3032165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2020
• 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: REFER H10 NARRATIVE; SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention