MAUDE Adverse Event Report: STRYKER GMBH HUMERAL INSERT TRIAL - 3 2MM X 8MM STANDARD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	5901-IS-3208
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that the patient's left shoulder was revised after patient complaint of pain and inability to lift her arm.Surgeon removed the cup and liner and noticed something in the posterior capsule.A trial device was removed.There are no allegations against any of the primary implants, which were implanted at another hospital by another surgeon.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.However, based on investigation, the root cause of the event is user related.The failure was caused by mistakenly implanting a trial device.The complaint event clearly states: "surgeon removed the cup and liner and noticed something in the posterior capsule.A trial device was removed." the ifu clearly states that: "stryker trial components should be used for size determination, preparation evaluation, trial reduction and range of motion evaluation, thus helping to preserve the integrity of the actual implants and their sterile packaging", which means that the trials are only used for sizing and should not under any circumstances be implanted.Furthermore, risk measures were taken in order to avoid these kind of events: it is clearly written on the trial device "trial do not implant" on one of the faces of the trial.The trials are all color coded differently than the implant in order to avoid confusion.The implant is white since it is made from uhmwpe, while the trials are either, green or black.In conclusion, this case can be classified as user related.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the patient's left shoulder was revised after patient complaint of pain and inability to lift her arm.Surgeon removed the cup and liner and noticed something in the posterior capsule.A trial device was removed.There are no allegations against any of the primary implants, which were implanted at another hospital by another surgeon.

• Brand Name: HUMERAL INSERT TRIAL - 3 2MM X 8MM STANDARD
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8545134
• Report Number: 0008031020-2019-00370
• Device Sequence Number: 1744078
• Product Code: KWS
• UDI-Device Identifier: 07613327100778
• UDI-Public: 07613327100778
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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: 5901-IS-3208
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 04/24/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR