MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-48; ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM

Model Number N/A

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Pain (1994); Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/13/2021

Event Type  Injury  

Event Description

Patient was implanted on an unknown side and post-implantation experienced loosening of the glenoid, left shoulder, general failure of the material and recurrent pain on the left side along with acute subacromial bursitis and right rib fracture, vd.For screw breakage and loosening of the glenoid component.

Manufacturer Narrative

Medical product: catalog#: 0104201072; lot#: unknown anatomical shoulder, humeral stem, uncemented, 7.Catalog#: 0104223106; lot#: unknown anatomical shoulder reverse, humeral cup.Catalog#: 0104223236; lot#: unknown anatomical shoulder reverse, glenoid head, 36.Catalog#: unknown; lot#: unknown inverse/reverse humeral pe-inlay generic.The manufacturer did not receive x-rays, or other source documents for review.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: 0009613350-2021-00571, 0009613350-2021-00572.Explantation unknown.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported that there was recurrent left should pain, loosening of the glenoid and screw breakage.Review of received data: no medical data 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: no product was returned; therefore, product 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 because the product identification is not available for all components.Dhr review: review of manufacturing records could not be performed due to missing lot numbers.Conclusion: it was reported that there was recurrent left shoulder pain, loosening of the glenoid and screw breakage.Neither medical records nor the devices or pictures thereof have been made available.Therefore, the course of events and the condition of the involved components remain unknown.Consequently, the reported event cannot be confirmed and possible causes could not be investigated due to the significant lack of information.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: ANATOMICAL SHOULDER REVERSE, SCREW SYSTEM, 4.5-48
• Type of Device: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM
• 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: 12793535
• MDR Text Key: 280680999
• Report Number: 0009613350-2021-00573
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00889024483064
• UDI-Public: 00889024483064
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K052906
• 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: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• 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: 01.04223.048
• 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: 01/20/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Sex: Female