MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 UNK SHOULDER HUMERAL CUP DELTA XTEND

Catalog Number UNK SHOULDER HUMERAL CUP DELTA

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problems Loss of Range of Motion (2032); Joint Dislocation (2374)

Event Date 07/12/2021

Event Type  Injury  

Event Description

It was reported the patient suffered a shoulder dislocation.Humeral cup is still implanted.

Manufacturer Narrative

Product complaint # (b)(4).The device catalog number is unknown; therefore, udi is unavailable.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: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

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.Removed the device code off label use.

Event Description

Additional information received indicates that it has been determined that on nov 11, 2021, the patient was revised due to dislocation.The components removed were: depuy delta xtend humeral stem, and depuy humeral cup, which were replaced with competitor products at this time.The depuy glenosphere was revised and replaced with a depuy glenosphere.The depuy metaglene was retained 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.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 returned to depuy synthes for evaluation.The photographs attached were reviewed, however they do not represent the current complaint condition.Therefore the investigation could not draw any conclusions about the reported event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot : a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

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.

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.

Manufacturer Narrative

Product complaint (b)(4) investigation summary the device associated with this report was not returned to depuy synthes for evaluation.The photographs attached were reviewed, however they do not represent the current complaint condition.Therefore the investigation could not draw any conclusions about the reported event.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a device history record (dhr) review or manufacturing records evaluation (mre) was not possible because the investigation was not able to retrieve the required lot code.

• Brand Name: UNK SHOULDER HUMERAL CUP DELTA XTEND
• Type of Device: SHOULDER HUMERAL CUP
• 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 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 16419430
• MDR Text Key: 310042904
• Report Number: 1818910-2023-04299
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK SHOULDER HUMERAL CUP DELTA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2023
• 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
• Treatment: DXTEND GLENOSPHERE STD D42MM.; DXTEND HUMERAL SPACER +9MM.; DXTEND MBLOC HUM EPI 1 D10 STD.; UNK SHOULDER GLENOSPHERE DELTA XTEND.; UNK SHOULDER GLENOSPHERE DELTA XTEND.; UNK SHOULDER HUMERAL EPIPHYSIS DELTA XTEND.; UNK SHOULDER HUMERAL STEM 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