MAUDE Adverse Event Report: STRYKER GMBH 4.5MM PERIPHERAL SCREW - 32MM; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 5572-4532

Device Problem Device Slipped (1584)

Patient Problems Fall (1848); Pain (1994)

Event Date 08/08/2018

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that patient's right shoulder was revised after patient suffered several falls and complained of pain.The glenoid baseplate was found to have loosened.Surgeon decided to use bone allograft in the glenoid and a humeral head on the existing stem.

Manufacturer Narrative

Investigation revealed the subject product to be a concomitant item.The device did not contribute to the reported event.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

Event Description

It was reported that patient's right shoulder was revised after patient suffered several falls and complained of pain.The glenoid baseplate was found to have loosened.Surgeon decided to use bone allograft in the glenoid and a humeral head on the existing stem.

• Brand Name: 4.5MM PERIPHERAL SCREW - 32MM
• Type of Device: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7848587
• MDR Text Key: 119324063
• Report Number: 0008031020-2018-00581
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 07613327098754
• UDI-Public: 07613327098754
• Combination Product (y/n): N
• PMA/PMN Number: K130895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/25/2018

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5572-4532
• Device Lot Number: 4658ND
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/08/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 08/30/2018
• Supplement Dates FDA Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 118