MAUDE Adverse Event Report: DEPUY CMW - 9610921 DEPUY/CMW 2G; BONE CEMENT : BONE CEMENT

Model Number 5450-32-500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Fatigue (1849); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330)

Event Date 06/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Trade name gentamicin sulphate.Active ingredient(s) gentamicin sulphate.Dosage form - powder.Strength 1.0g active in our cements.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Clinical adverse event received for stiffness - s/p tsa : arthrofibrosis.Event is serious and is considered moderate.Event is definitely not related to device and is possibly related to procedure.Date of implantation: (b)(6) 2018.Date of event (onset): (b)(6) 2020.(left shoulder).Treatment: patient underwent manipulation under anesthesia, transarthroscopic lysis of adhesions and capsular release.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Medical records received and reviewed: it is noted the date of left shoulder manipulation under anesthesia occurred on (b)(6) 2020.In addition to the previously reported issues, the patient was also experiencing the following adverse symptoms prior to left shoulder manipulation under anesthesia on (b)(6) 2020: pain, discomfort, decreased range of motion, and weakness.Evaluation notes following the left shoulder manipulation revealed improving symptoms.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Depuy synthes considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Based on the inability to find any nc¿s against the provided product code/lot code combination, it is reasonable to conclude that there are no anomalies with regard to manufacturing or inspection contained in the device history records that would contribute to the reported event.

• Brand Name: DEPUY/CMW 2G
• Type of Device: BONE CEMENT : BONE CEMENT
• Manufacturer (Section D): DEPUY CMW - 9610921; cornford rd; blackpool IN FY4 4 QQ; UK FY4 4QQ
• MDR Report Key: 11176053
• MDR Text Key: 227008377
• Report Number: 1818910-2021-01203
• Device Sequence Number: 1
• Product Code: MBB
• UDI-Device Identifier: 10603295174271
• UDI-Public: 10603295174271
• Combination Product (y/n): Y
• PMA/PMN Number: K081163
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup
• Report Date: 01/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5450-32-500
• Device Catalogue Number: 545032500
• Device Lot Number: 8793495
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CROSSLINK ANCHOR PG GLENOID 52; DEPUY/CMW 2G; GLBL UNITE ANT BODY 135 SZ 12; GLOBAL UNITE HEAD 52X21 ECC; GLOBAL UNITE STD STEM SZ 12; CROSSLINK ANCHOR PG GLENOID 52; DEPUY/CMW 2G; GLBL UNITE ANT BODY 135 SZ 12; GLOBAL UNITE HEAD 52X21 ECC; GLOBAL UNITE STD STEM SZ 12
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 96