MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN REUNION TSA SHOULDER; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number UNK_SEL

Device Problem Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device remains implanted.

Event Description

The patient reported she had a shoulder replacement on (b)(6) 2001; she alleges the implant is now squeaking.No other information has been provided at this time.

Event Description

The patient reported she had a shoulder replacement on (b)(6)2001; she alleges the implant is now squeaking.No other information has been provided at this time.Update-(b)(6) 2021 8 months after surgery patient started hearing the noise in her shoulder.Surgery took place on the (b)(6), 2020.Update-(b)(6)2021 had a phone call with the patient.She mentioned that the squeaking hasn't been as bad lately, she normally notices it throughout the day and that hasn't been the case over the last couple of days.She is not sure if this means this issue will resolve itself or if this is needs to be addressed surgically.She is not especially keen on having to have surgery to address this issue if it does not resolve itself.Update-(b)(6)2021 patient had a visit with her physician and provided the reporter a list of information we'd be looking for and she mentioned that the squeaking continued and her physician stated the patient might need a revision if the issue doesn't stop.Patient is not interested in revision or following up with this issue at this moment, the physician offered a follow up consultation to the patient with other surgeon that has more experience with these products but told the patient that this issue is annoying but not a big deal.The patient mentioned that she notices the squeaking is inconsistent and happens mostly at night and wonders if it is an issue with her muscles.She is satisfied with the functionality of the product and will reach out if she decides to follow up with this issue in the future.

Manufacturer Narrative

Please note update to b5, g1 mfg site the alleged event could not be confirmed, since the item was still implanted; no evidence was provided.Manufacturing documents and exact labelling and exact rmf could not be reviewed since no lot-no was provided.The shoulder prosthesis could belong to 3 different brands.On (b)(6) 2021, after having consulted her physician the patient reported she is satisfied with the functionality of the product and will reach out if she decides to follow up with this issue in the future.A physical investigation was not possible because the prosthesis was not available because implanted; a root cause for noise could not be determined.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.The file will be closed formally.In case the item and / or relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.

• Brand Name: UNKNOWN REUNION TSA SHOULDER
• Type of Device: 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; postfach; mahwah NJ 07430
• Manufacturer Contact: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12494968
• MDR Text Key: 273308998
• Report Number: 0008031020-2021-00416
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/20/2021
• Supplement Dates Manufacturer Received: 11/24/2021
• Supplement Dates FDA Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 68 KG