MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH UNKNOWN (HUMERAL BEARING); EXTREMITIES PROSTHESIS

Model Number N/A

Device Problems Material Disintegration (1177); Patient Device Interaction Problem (4001)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2021

Event Type  Injury  

Manufacturer Narrative

Medical product: anatomical shoulder, humeral stem, cemented, 14 catalog#: 01.04211.142; lot#: 2322858.Anatomical shoulder, reverse, humeral cup, 0, retro catalog#: 01.04223.100 ; lot#: unknown.The manufacturer did not receive x-rays, or other source documents 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.Zimmer biomet¿s reference number of this file is (b)(4).The following reports are associated with this event: 0009613350-2021-00628.

Event Description

It was reported that the revision of old anatomic reverse shoulder due to notching causing the bearing to wear out.Patient outcome, revision.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported that an anatomical reverse shoulder replacement had to be revised due to notching and wear of the bearing.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.Three photographs were received.Image 1: humeral cup and humeral inlay attached to each other with blood on the visible surfaces and positioned in a tray.Image 2: humeral stem on a blue surgical drape with visible labeling and some blood on the visible surfaces.Image 3: undated radiograph which cannot be evaluated in more detail due to poor image quality.Otherwise, no medical data relevant to the case has been received.Product evaluation: the products were discarded; 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 could not be performed due to missing product identification.Dhr review: review of the device history records could not be performed due to missing product identification.Conclusion: it was reported that an anatomical reverse shoulder replacement had to be revised due to notching and wear of the bearing.The devices were discarded, and no medical records such as surgical reports and labeled radiographs (dated, view) were provided.Based on the images provided, a detailed assessment could not be performed.Therefore, the reported event cannot be confirmed and a root cause analysis could not be performed.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).

Event Description

No change to previously reported event.

• Brand Name: UNKNOWN (HUMERAL BEARING)
• Type of Device: EXTREMITIES PROSTHESIS
• 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: 12909100
• MDR Text Key: 284182917
• Report Number: 0009613350-2021-00629
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention