MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 STAND CUP TRIAL D42 +3MM; EXTREMITY INSTRUMENTS : HUMERAL TRIALS

Catalog Number 230742403

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

Patient Problems Loss of Range of Motion (2032); Foreign Body In Patient (2687)

Event Date 08/28/2023

Event Type  Injury  

Event Description

Via user report: the affected person was first provided with osteosynthesis in the case of a forearm fracture and then, in the same session, was given the shoulder prosthesis using the medical device described above.45 minutes before the end of the operation, an emergency (ileus) had to be introduced and the person with the function "opspringer" additionally had to be looked after in a third operating room.All the instruments used in the operation went to the aemp for preparation immediately after the end of the operation.The aemp's on-duty sterile specialist immediately noticed the missing test implant for the xtend humerus-pe inlay std 42+3mm and immediate feedback was received to the surgeon and the surgical team.The immediate control of all discharge containers was unsuccessful.The sample implant was not found.Findings of the postoperative x-ray inspection of the shoulder: no evidence for radiopaque foreign bodies findings of the ct-inspection of (b)(6): no foreign material can be detected or detected inlay in correct position the patient was discharged from the hospital after treatment was completed.Postoperative abnormalities were not recognizable.The affected person presented himself in another clinic with movement restrictions.There, the erroneously remaining test implant was surgically removed.Conclusion from our point of view: the sample material must be manufactured radiopaque in order to increase patient safety.

Manufacturer Narrative

Product complaint # (b)(4).Additional event information: no surgical delay reported.As the trial was implanted in error, a revision was performed in another unknown hospital.There, surgical removal of the mistakenly remaining trial implant was performed.There was no allegation against the device, but the customer requests that the trial material must be produced radiopaque to increase patient safety.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4) investigation summary: no device associated with this report was received for examination.Product code: 230742403.Lot number: 5415997.Product description: stand cup trial d42 +3mm dhr details : 1) quantity manufactured: (b)(4) 2) date of manufacture: 23/06/2022 3) any anomalies or deviations identified in dhr: no 4) expiry date: n/a 5) ifu reference: w90966 as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: dhr details : 1) quantity manufactured: (b)(4) 2) date of manufacture: 23/06/2022 3) any anomalies or deviations identified in dhr: no 4) expiry date: n/a 5) ifu reference: w90966.

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 synthese joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthese 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.

• Brand Name: STAND CUP TRIAL D42 +3MM
• Type of Device: EXTREMITY INSTRUMENTS : HUMERAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 17873378
• MDR Text Key: 324961383
• Report Number: 1818910-2023-20174
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 10603295115885
• UDI-Public: 10603295115885
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 230742403
• Device Lot Number: 5415997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Required Intervention
• Patient Sex: Female