MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH GLENOSPHERE, 36 0; N/A

Model Number N/A

Device Problems Loss of Osseointegration (2408); Contamination /Decontamination Problem (2895); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Unspecified Infection (1930)

Event Date 01/21/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: anaverse baseplate extremities impl win gen; catalog#: unknown; lot#: unknown.Anatomical stem extremities impl win gen; catalog#: unknown; lot#: unknown.Reverse cup extremities impl win gen; catalog#: unknown; lot#: unknown.Concomitant medical products - therapy date: (b)(6) 2021.The manufacturer did receive per for review.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.(b)(4).

Event Description

Patient was implanted on the right side and underwent revision surgery due to infection and loosening.

Manufacturer Narrative

Additional information which was received on feb 10, 2021.D10 - medical product : baseplate, xs, 25mm; item# 0104440005; lot# 4502916891.Anatomical shoulder, humeral stem, cemented, 9, 100 mm; item# 0104211093; lot# 2927843.Anatomical shoulder, reverse, humeral cup, 0, retro, +6 mm medial offset; item# 0104223106; lot# 3024629.Anatomical shoulder reverse, humeral insert, pe, 36-0; item# 0104223360; lot# 3012139.This follow-up report is being filled to relay additional information, which was unknown at the time of the previous medwatch.The manufacturer received reference and lot numbers which will reviewed as part of ongoing investigation.Should any additional information become available or 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

Patient was implanted on the right side and underwent revision surgery due to infection and loosening.

Event Description

Investigation has been completed.

Manufacturer Narrative

Investigation results were made available.Event description: it was reported that the patient was implanted on (b)(6) 2020 and underwent revision surgery on (b)(6) 2021 primarily due to infection.Before noticeable infection, the baseplate has broken out and it is still unclear why this occurred as there was no traumatic event in the form of a fall or something similar.It was noticed that the connection (sleeve at the tm post) was loosened.Review of received data: no medical data relevant to the case has been received.Due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: visual examination: in the as-received condition the tm sleeve was still fixed to the central post of the anaverse glenoid baseplate.The locking cap was not sent for investigation.The sleeve was removed during the cleaning and disinfection process.Except for some scratches and smearings there is nothing to report about the anaverse glenoid glenosphere.The anaverse glenoid taper adapter is still mounted in the taper of the baseplate.The taper of the taper adapter exhibits a seating pattern as well as two scratched zones and individual scratches and nicks.The surface of the baseplate facing the glenosphere is inconspicuous.The two dpsc screws used for anchoring the baseplate are also still located in the baseplate¿s screw holes.Small line-shaped and more pronounced polished zones can be seen in the superior half of the baseplate¿s anchoring side.On both dpsc screws there are areas on the thread where the color anodization has a bluish appearance or is no longer visible.On the inferior (longer) screw the area, where the color anodization is no longer visible, has a polished appearance and thread is slightly deformed.The central post of the baseplate exhibits an area with line-shaped smears on the posterior side and an elliptical-shaped area with a mixture of slight wear and smearing of approximately 7 mm in length on the anteroinferior side.In the tm sleeve a hole can be observed that is surrounded by a polished area where the material thickness is thinned.Putting the sleeve over the central post, the hole in the sleeve matches the elliptical-shaped area.The sleeve itself is not deformed.Further, a polished stripe close to the hole as well as remains of bone in the tm structure are recognizable.Approximately one third of the rim of the anatomical shoulder reverse humeral insert is abraded.On the immediately adjacent area of the articulation surface the machining marks are still recognizable and coarse scratches are present.To the latter area an area showing abrasion, scratches and indented shiny polished metal particles joins.The insert¿s anchoring side is inconspicuous except for cuts probably deriving from the removal of the insert from the cup.When mounting as far as possible the insert in the humeral cup it is obvious that a stripe of the cup is no longer covert by polyethylene.The stripe is located on the lower side of the cup¿s rim, has a length of about 15 mm and a polished appearance.There, the rim¿s edge is worn and slightly deformed downward.Further, the cup¿s lateral area is scratched on the lower side and shows as well scratches on the upper side.One of the rim¿s slots is damaged probably due to the revision surgery.On the cup¿s taper marks of a seating pattern and some artefacts are visible.There are some fine scratches on the cup¿s rear side.There are no remains of cement on the anchoring surface of the anatomical shoulder humeral stem.The stem is damaged by scratches, nicks and so on in the proximal region.The taper exhibits a seating pattern and some artefacts.Review of product documentation: device purpose: all involved devices are intended for treatment.Product compatibility: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Sterilization certificate: the sterilization specification of the devices certifies the suitability of sterilization.The irradiation certificate of the affected lot number has been reviewed and was found to be according to specifications.Conclusion: it was reorted that the patient was implanted on (b)(6) 2020 and underwent revision surgery on (b)(6) 2021 primarily due to infection.Before noticeable infection, the baseplate has broken out and it is still unclear why this occurred as there was no traumatic event in the form of a fall or something similar.It was noticed that the connection (sleeve at the tm post) was loosened.After approximately 9 months in vivo the total shoulder prosthesis was revised primarily due to infection.It was reported that already before the infection the baseplate of the anaverse glenoid was loose and displaced.The patient did not experience a trauma.It was found conspicuous that a connection (sleeve at tm post) had been separated.However, in the as-received condition the tm sleeve was found fixed to the central post of the anaverse glenoid baseplate, but the locking cap preventing the sleeve to detach from the post was missing and not provided for investigation.The sleeve was then removed during the cleaning and disinfection process.The appearance of the retrieved components at hand points to the occurrence of scapular notching as reported in.Due to contact between the scapula and the humeral cup the rim of the insert could have been abraded.As there is no clinical information including x-rays for evaluation at hand it can only be hypothesized that the scapular bone was eroded beyond the inferior anchoring screw.This could possibly allow contact between the edge of the cup¿s rim and the inferior screw.It could be that the erosion of the bone maybe in combination with an infective situation progressed to such a state that the inferior screw was no longer anchored in the bone leading to the loosening and displacement of the anaverse baseplate.The small line-shaped and more pronounced polished zones seen in the superior half on the anchoring side of the baseplate could point to movement of the baseplate against the bone.It remains unknown where from the hole in the tm sleeve derived.The investigation did not identify a nonconformance or a complaint out of box (coob).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).The following reports are associated with this event: 0009613350-2021-00095-2, 0009613350-2021-00091-2, 0009613350-2021-00089-2, 0009613350-2021-00096-2, 0009613350-2021-00100-1.

• Brand Name: GLENOSPHERE, 36 0
• Type of Device: N/A
• 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: 11336436
• MDR Text Key: 232152561
• Report Number: 0009613350-2021-00089
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: N/A
• 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: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• 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: 01.04440.068
• Device Lot Number: 3015759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2019
• 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 NARRATIVE; SEE H10 NARRATIVE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female