MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER SYSTEM/ANATOMICAL SHOULDER DOMELOCK SYSTEM/ANATOMICAL SHOULD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number N/A

Device Problems Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: therapy date: unknown.X-rays and photographs were received and will be reviewed as part of ongoing investigation.The complaint device has been returned, but the device investigation has not yet been completed.Once the evaluation is completed, a supplemental medwatch 3500a will be submitted.The lot number of the device was received.The device history records will be reviewed during investigation.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).The following reports are associated with this event: 0009613350-2021-00580; 0009613350-2021-00581.

Event Description

It was rported that, head became disassociated from the stem.Patient outcome- revision.

Manufacturer Narrative

This follow-up report is being filled to relay additional information, which was unknown at the time of initial medwatch.New information received: explantation date, patient dob, weight, height, bmi and all relevant history: age 53, no other information available.Investigation of this incident is currently ongoing, a follow up report will be submitted when additional information becomes available.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2021-00580-1; 0009613350-2021-00581-1.

Event Description

It was reported that, head became disassociated from the stem.Patient outcome- revision.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Updated: h2, h6, h10 event description: it was reported that the patient underwent primary implantation on (b)(6) 2019 and underwent revision surgery on (b)(6) 2021 due to disassociation of the humeral head from the stem.Summary of retrieval analysis: the returned retrieval was reviewed and investigated by the zimmer biomet research department.This outcome of the investigation can be summarized as follows: after 2 years and 8 months in vivo the anatomical shoulder humeral parts were revised due to a disassociation of the head from the stem.The only clinical information at hand is an ap view x-ray taken a few weeks before the revision surgery.The x-rays shows: gap between the bottom of the head and the bone in the proximal half gap between the implant and the bone around the stem¿s most proximal part small zone at the stem¿s tip having a similar brightness like the cortical bone possible radiolucent line along the stem¿s medial side and a small osteolytic zone sclerotic line along the cortical bone on the medial side unusually long distance between the proximal end of the stem and the bottom of the head being medially shorter than laterally.However, as there is no complete x-ray follow-up at hand the bone situation as well as the position of the implants and any changes occurring throughout the time in vivo remain unknown.It can only be assumed that the above findings could possibly indicate a loosening and subsidence of the stem.In the blasted area of the humeral stem short slightly polished lines can be seen under certain lighting conditions and there are no signs of bone ongrowth visible.This could as well point to a loosening of the stem.Concerning the taper connection between the head and the stem the situation seen on the x-ray could indicate that the t-dome taper appears to be slightly tilted to distal and is no longer fully seated in the stem¿s taper.The polished stripes observed on both tapers can probably be ascribed to movement of the t-dome / head construct in the stem¿s taper leading to some wear.On the t-dome taper parts of a seating pattern could be detected.This indicates that the t-dome taper was in contact with the stem¿s taper in the intended position.However, it remains unknown if the connection was firmly fixed.The polished areas on the head¿s bottom surface indicate that the head moved on the humeral bone.It is unknown if this occurred already before the disassociation of the head and could have somehow contributed to it or if it is only a concomitant phenomenon.Review of product documentation and due diligence: - all involved devices are intended for treatment.- device history records (dhr): the quality records show that all specified characteristics have met the specifications valid at the time of production with no ncr with a potential correlation to the reported event was found.- product compatibility: the product combination was approved by zimmer biomet.- no further due diligence required as all required information to support the conclusion is available/was already requested.Summary: it was reported that the patient underwent primary implantation on (b)(6) 2019 and underwent revision surgery on (b)(6) 2021 due to disassociation of the humeral head from the stem.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 received x-ray image taken a few weeks before the revision surgery could possibly indicate a loosening and subsidence of the humeral stem.Further, the received humeral stem has short slightly polished lines in the blasted area and no signs of bone ongrowth is visible.Additionally, the taper connection between the head and stem on the x-ray appears slightly tilted and no longer fully seated in the stem's taper.Polished stripes on both tapers can probably be ascribed to movement between the two.On the t-dome taper parts of a seating pattern could be detected.This indicates that the t-dome taper was in contact with the stem¿s taper in the intended position.However, it remains unknown if the connection was firmly fixed.The polished areas on the head¿s bottom surface indicate that the head moved on the humeral bone.It is unknown if this occurred already before the disassociation of the head and could have somehow contributed to it or if it is only a concomitant phenomenon.No complete x-ray follow-up was provided.Therefore, based on the received information and the investigation it is not possible to find out the source of the different phenomenas and at what point in time they occurred.Based on the given information and the results of the investigation, we were not able to identify a specific root cause for the reported issue.No corrective actions, preventive actions, or field actions resulted after investigation of this event.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).

Event Description

No change to previously reported event.

• Brand Name: ANATOMICAL SHOULDER SYSTEM/ANATOMICAL SHOULDER DOMELOCK SYSTEM/ANATOMICAL SHOULD
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• 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: 12834684
• MDR Text Key: 280932100
• Report Number: 0009613350-2021-00579
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00889024485297
• UDI-Public: 00889024485297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• 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: 01.04212.505
• Device Lot Number: 2867863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2016
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male