MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH TM SCREW EXTREMITIES IMPL

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Loss of Range of Motion (2032); Tingling (2171); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: ext-tm reverse baseplate; item# unknown; lot# unknown ext-tm reverse glenosphere; item# unknown; lot# unknown ext-tm reverse spacers; item# unknown; lot# unknown ext-tm reverse poly liners; item# unknown; lot# unknown ext-tm reverse stem; item# unknown; lot# unknown 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.Additional information has been requested and is currently not 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.(b)(4).

Event Description

Patient was implanted on left side and started experiencing tingling, numbness, loss of range of motion and nerve damage.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected and additional information.Additional: h2, h6.Correction: b4, g4, g7, h10.It was confirmed that all products involved in this event are warsaw-design-products.Please invalidate this case from your system.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).

• Brand Name: TM SCREW EXTREMITIES IMPL
• Type of Device: TM SCREW EXTREMITIES IMPL
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• MDR Report Key: 10641841
• MDR Text Key: 210361500
• Report Number: 0009613350-2020-00449
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: No
• 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 the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 47