MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND HUMERAL SPACER +9MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL SPACER

Model Number 130730009

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

Patient Problems Fall (1848); Pain (1994); Pneumonia (2011); Loss of Range of Motion (2032); Discomfort (2330); Joint Laxity (4526); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient was treated with a right shoulder prosthetics on the (b)(6) 2020 due to an unknown reason.During recovery the patient fell due to which a revision needs to take place.Because the patient has a nickel allergy a nickle free psi has been requested.

Event Description

Primary operative notes dated (b)(6) 2020 indicated that the patient received a right reverse shoulder replacement due to severe defect arthropathy on the right.It was indicated that the patient has a known nickel allergy prior to the primary implantation.Due to the patient's significant natural joint defects, an appropriate titanium glenosphere was preoperatively fabricated, as in a custom-made prosthesis.The surgery was completed without indication of complication by the surgeon.Trauma consultation dated (b)(6) 2020 indicated that the patient was experiencing immobility syndrome and a dislocation of the reverse shoulder prosthesis on the right, radiologically suspected dislocation of the glenosphere.It was also indicated that the patient had dislocation of socket in a patient with a shoulder prosthesis on the left.Repositioning of the right shoulder joint was not possible.Treatment included osteoporosis therapy, 15-degree abduction pillow for 4-5 weeks, guided motion exercises and analgesia as needed.It was indicated that over the course of the patient¿s hospital stay in (b)(6) 2020, the patient developed hyponatremia, and was treated with intravenous sterofundin.It was also indicated that the patient was positive for sars-cov-2 and viral pneumonia.There was no indication that a revision surgery had occurred at this time.

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.Appropriate term / code not available (e2402) is used to capture generalized disorders (e23).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot: a dhr review was conducted: 1) quantity manufactured: 20.2) date of manufacture: (b)(6) 2016.3) any anomalies or deviations identified in dhr: none.4) expiry date: 30-apr-2021.5) ifu reference: (b)(4).

Manufacturer Narrative

Product complaint #
=
> pc-(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.H10 additional narrative: added: d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.

Manufacturer Narrative

Product complaint # : pc-(b)(4).Investigation summary : examination of the returned device could not confirm the reported event.The investigation found no evidence of product malfunction or product error and the need for corrective action was not indicated.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.The investigation found no evidence of product error as a contributing factor to the reported event and the need for corrective action was not indicated.Device history lot : a dhr review was conducted: 1) quantity manufactured: (b)(4).2) date of manufacture: 11-may-2016.3) any anomalies or deviations identified in dhr: none.4) expiry date: 30-apr-2021.5) ifu reference: (b)(4).

• Brand Name: DXTEND HUMERAL SPACER +9MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL SPACER
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• MDR Report Key: 11076985
• MDR Text Key: 223760262
• Report Number: 1818910-2020-27647
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027348
• UDI-Public: 10603295027348
• Combination Product (y/n): N
• PMA/PMN Number: K120174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 130730009
• Device Catalogue Number: 130730009
• Device Lot Number: 5269007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Date Manufacturer Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CTM DELTA GLENOSPHERE STD D42; DXTEND MOD CENT EPI 1 HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND STAND PE CUP D42 +6MM; GLOBAL UNITE STD STEM SZ 12; METAGLENE +10MM; CTM DELTA GLENOSPHERE STD D42; DXTEND MOD CENT EPI 1 HA; DXTEND SCREW LOCK D4.5X24MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND SCREW LOCK D4.5X36MM; DXTEND STAND PE CUP D42 +6MM; GLOBAL UNITE STD STEM SZ 12; METAGLENE +10MM
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR