MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 DXTEND HUMERAL SPACER +9MM; DELTA XTEND IMPLANTS : SHOULDER HUMERAL SPACER

Model Number 130730009

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Loss of Range of Motion (2032); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2021

Event Type  Injury  

Event Description

An unknown office seeked for assistance at johnson and johnson medical devices emea.They wrote: "dear sir or madam, our client was the victim of an attempted homicide and has been unable to move her right arm since the implantation of a shoulder tep.In the meantime, she has already had several revisions performed on the right side, all of which were of no avail.The tep continues to dislocate.Most recently, she was implanted with the prosthesis from the company exactech, model equinox reverse.The stem is still from the company delta x-tend.As the manufacturer, can you identify and name the recurrent dislocation problem? is it possible that the two components do not harmonize with each other? can you name several doctors in germany who regularly work with these prostheses and could eliminate the problem? thank you very much for your efforts.With kind regards matterne & partner".

Manufacturer Narrative

Product complaint # (b)(4).Initial reporter occupation: lawyer.Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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 medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : the device associated with this report was not returned to depuy synthes for evaluation.It is understood there is no allegation associated with this product malfunction.No visible damage or anything indicative of a device nonconformance was found during the investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : 1) quantity manufactured: (b)(4).2) date of manufacture: 04 nov 2020 3) any anomalies or deviations identified in dhr: none 4) expiry date: 31 oct 2025 device history review : 1) quantity manufactured: (b)(4).2) date of manufacture: 04 nov 2020 3) any anomalies or deviations identified in dhr: none 4) expiry date: 31 oct 2025.

Event Description

On (b)(6) 2021, radiograph shows right shoulder has luxated again.On (b)(6) 2021, revision of right shoulder tep.The delta extend model is removed and another tep form exactech, equinox reverse model was used.The shaft was not replaced.Doi: (b)(6) 2021; dor: (b)(6) 2021; right shoulder.

• Brand Name: DXTEND HUMERAL SPACER +9MM
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL SPACER
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17198617
• MDR Text Key: 317985305
• Report Number: 1818910-2023-12949
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027348
• UDI-Public: 10603295027348
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K192855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 130730009
• Device Catalogue Number: 130730009
• Device Lot Number: 5371982
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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
• Treatment: DXTEND GLENOSPHERE STD D42MM; DXTEND MBLOC HUM EPI 1 D10 STD; UNK SHOULDER HUMERAL CUP DELTA XTEND; UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER LOCKING SCREW; UNKNOWN SHOULDER METAGLENE
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female