MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 16MM; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5572-4516
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event	08/19/2021
Type of Reportable Event	Serious Injury
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.H3 other text: device is retained by hospital or patient.
Event or Problem Description
As reported: "i am writing to draw your attention to a distressing medical incident involving the failed stryker reunion right shoulder replacement surgery on (b)(6) 2020.The procedure took place at (b)(6).Regrettably, despite enduring nine months of persistent pain and limited range of motion, i underwent revision surgery on (b)(6) 2021.Preoperative diagnosis: right shoulder failed reverse total shoulder arthroplasty, axillary nerve neuropraxia.Postoperative diagnosis: cat scan evaluation of the shoulder revealed an os acromiale and a fracture line around the humeral endoprosthesis with proximal loosening.Initial stages of scapular notching was noted.The metaphyseal portion of the humeral endoprosthesis was inferior and slightly medial to the inferior aspect of the glenoid.The center of rotation of the reverse total shoulder arthroplasty appeared nonlateralized.".
Additional Manufacturer Narrative
The reported event could be confirmed with the radiographic changes which align with the described event of pain.From the available radiographs, a formal medical opinion was sought:- the available radiographs showed some periprosthetic proximal/lateral osteolysis, without sure signs of loosening of the humeral stem.The line of a well-healed osteotomy was visible on the x-rays.The x-rays also showed stage i scapular notching (early stage).The use of a thin oscillating saw blade to free the reunion humeral stem from the bone, illustrated that it was well-fixed below the small area of radiolucency.There are no signs of breakage/disassembly visible on radiographs.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.We've thoroughly checked all relevant historical data for the mentioned catalog number, and we confirm that there haven't been any recalls within the specified time frame.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported 'after nine months of persistent pain and limited range of motion, a patient underwent revision surgery.Preoperative diagnosis: right shoulder failed reverse total shoulder arthroplasty, axillary nerve neuropraxia.Postoperative diagnosis: cat scan evaluation of the shoulder revealed an os acromiale and a fracture line around the humeral endoprosthesis with proximal loosening.Initial stages of scapular notching was noted.The metaphyseal portion of the humeral endoprosthesis was inferior and slightly medial to the inferior aspect of the glenoid.The center of rotation of the reverse total shoulder arthroplasty appeared nonlateralized.".

• Brand Name: 4.5MM PERIPHERAL SCREW - 16MM
• 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: 17460593
• Report Number: 0008031020-2023-00288
• Device Sequence Number: 12539145
• Product Code: KWS
• UDI-Device Identifier: 07613327098716
• UDI-Public: 07613327098716
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K202289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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: 5572-4516
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 09/19/2023
• 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: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 72 KG
• Patient Ethnicity: Hispanic