MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNKNOWN SCREW LENGTH 36; SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Numbness (2415)

Event Date 03/29/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02636, 0001822565-2022-02637, 0001822565-2022-02638, 0001822565-2022-02676, 0001822565-2022-02678.Medical products: item#: 00434901213, 12mm a 130mm length humeral stem; lot#: 62248463, item#: 00434903603, 36mm a +3mm offset poly liner; lot#: 62114032, item#: 00434903611, 36mm a glenosphere; lot#: 62234748, item#: 00834902502, tm rvs base plt 25mm post +2; lot#: 62274777, item#: unknown, unknown screw length 42; lot#: unknown, item#: unknown, unknown glenoid bone void filler- autograft (glenoid); lot#: unknown, item#: unknown, unknown simplex cement; lot#: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that a patient underwent a right reverse shoulder arthroplasty.Subsequently, approximately a month and a half after the surgery the patient reported an increase of pain down their arm.The patient was diagnosed with nerve pain with numbness and prescribed a medication (lyrica 75mg).The patient is satisfied and all implant remain implanted.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02636-1; 0001822565-2022-02637-1; 0001822565-2022-02638-1; 0001822565-2022-02676-1; 0001822565-2022-02678-1.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were provided and reviewed by a health care professional and a timeline was created.Review of the available records identified the following: (b)(6) 2013; visit improving; satisfied anteroposterior & axillary images taken: no significant findings ae increase in pain due to suspected nerve pain; prescribed lyrica 75 mg a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: UNKNOWN SCREW LENGTH 36
• Type of Device: SHOULDER PROSTHESIS, REVERSE CONFIGURATION/EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 15418944
• MDR Text Key: 299869884
• Report Number: 0001822565-2022-02677
• Device Sequence Number: 1
• Product Code: PHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2022
• 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
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White