MAUDE Adverse Event Report: STRYKER GMBH X3 HUMERAL INSERT - 36MM X 4MM STANDARD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5571-S-3604
Medical Device Problem Codes	Break (1069); Fracture (1260); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Nerve Damage (1979); Loss of Range of Motion (2032); Osteolysis (2377); 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) medical center, located 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 not be confirmed as the product was not returned and no signs of loosening were visible on the available radiographs.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.".
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.".
Additional Manufacturer Narrative
Please note correction to the imdrf clinical code.The reported event could not be confirmed.Although the device was returned for evaluation, we cannot confirm the alleged event.Additionally, in the provided radiographs, there are no signs of loosening.All the returned devices were verified; however, we did not find any visible damages on the device, excluding the minor scratches which can be from implantation or explantation.We have seen one end of the baseplate screw is broken which may be at the time of explantation.They show some remnants of bone ingrowth on the proximal humerus, confirming that the stem was at least partially well-fixed to the bone.A functional test was performed with the returned product where all screws could be locked in the baseplate without any concerns and cones for the press fit are functional as required.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 for the reported lot did not indicate any abnormalities.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.No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation the event could not be confirmed and root cause can not be established.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.".
Additional Manufacturer Narrative
Please note correction to d9.The reported event could not be confirmed since the device was returned for evaluation, we cannot confirm the alleged event and in the provided radiographs there are no signs of loosening.All the returned devices were verified we did not find any visible damages on the device, excluding the minor scratches which can be from implantation or explantation.We have seen one end of the baseplate screw is broken which may be at the time of explantation.They show some remnants of bone ingrowth on the proximal humerus, confirming that the stem was at least partially well-fixed to the bone.A functional test was performed with the returned product where all screws could be locked in the baseplate without any concerns and cones for the press fit are functional as required.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 for the reported lot did not indicate any abnormalities.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.No indications of material, manufacturing or design related problems were found during the investigation.Based on the investigation the event could not be confirmed and root cause can not be established.If any additional information is provided, the investigation will be reassessed.

• Brand Name: X3 HUMERAL INSERT - 36MM X 4MM STANDARD
• 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: 17469208
• Report Number: 0008031020-2023-00296
• Device Sequence Number: 17601591
• Product Code: KWS
• UDI-Device Identifier: 07613327098457
• UDI-Public: 07613327098457
• 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,Followup,Followup
• Report Date (Section B): 10/17/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/30/2025
• Device Catalogue Number: 5571-S-3604
• Device Lot Number: 1X3N76
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 08/22/2023; 08/19/2024; 09/19/2024
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 09/19/2023; 09/18/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2020
• 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