MAUDE Adverse Event Report: STRYKER GMBH HUMERAL CUP - 36MM DIA X 4MM THK; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5570-3604
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Loss of Range of Motion (2032)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "a post-market clinical evaluation of the reunion reverse.Shoulder arthroplasty (rsa) system: subject 01-004r postoperative heterotopic ossification, symptomatic.Superior glenoid ho, patient was struggling with occasional soreness/tightness subject sent back to physical therapy to improve range of motion and stiffness".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.

• Brand Name: HUMERAL CUP - 36MM DIA X 4MM THK
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18606772
• Report Number: 0008031020-2024-00049
• Device Sequence Number: 13047827
• Product Code: KWS
• UDI-Device Identifier: 07613327098365
• UDI-Public: 07613327098365
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K202289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 5570-3604
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 79 KG