MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DXTEND MOD EPI 1 ECC LEFT HA; DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY

Model Number 130720102

Device Problems Device Dislodged or Dislocated (2923); Naturally Worn (2988); Noise, Audible (3273)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/12/2021

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 underwent left delta xtend total shoulder replacement in (b)(6) 2019.Presented back to surgeon complaining of pain in left shoulder and what they described as a 'clicking' in the shoulder joint upon movement.Procedure today to explore the left shoulder and proceed as necessary.Upon opening the shoulder the surgeon noted the presence of metallosis in the soft tissues.The surgeon remarked that this seemed to be concentrated around the top of the humerus, around the epiphysis.The surgeon removed the poly insert form the epiphysis and the glenosphere from the metaglene.He examined both components and was unable to see any obvious damage or evidence of rubbing on either component.The metaglene was determined to be well fixed and was not revised.He then turned his attention to the humeral component, which was a modular, uncemented prosthesis.He noted the presence of metallosis around the proximal humerus.He removed the epiphysis and examined it, noting that some ha coating appeared to be rubbed off the prosthesis (see photos in attachment).The stem was very well fixed and not revised.The area was debrided and washed out and new prosthesis of the same specifications were re-implanted (ie.Epiphysis, poly insert and glenosphere).The surgeon suggested two possible causes of the metallosis.The epiphysis was not secure on the stem and had been backside rubbing on the stem.The 'fibrewire' suture he used in re-attaching the tuberosities had rubbed against the side of the epiphysis causing the removal of the ha coating and subsequent debris formation.

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: examination of the returned device could not confirm the reported event.This analysis does not highlight any supplier defect and the need of corrective actions is 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.Device history lot: the dhr analysis of the batch returned shows an initial conformance of this product with regards to its specification.For this batch, there were no deviation or non-conformances.See analysis report for full details.Corrected: h3.

• Brand Name: DXTEND MOD EPI 1 ECC LEFT HA
• Type of Device: DELTA XTEND IMPLANTS : SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 12254112
• MDR Text Key: 264737256
• Report Number: 1818910-2021-16642
• Device Sequence Number: 1
• Product Code: HSD
• UDI-Device Identifier: 10603295027294
• UDI-Public: 10603295027294
• Combination Product (y/n): N
• PMA/PMN Number: K192448
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130720102
• Device Catalogue Number: 130720102
• Device Lot Number: 5345096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 07/30/2021
• Supplement Dates Manufacturer Received: 08/10/2021; 09/29/2021
• Supplement Dates FDA Received: 08/17/2021; 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DXTEND GLENOSPHERE STD D42MM; DXTEND GLENOSPHERE STD D42MM; DXTEND METAGLENE; DXTEND MOD EPI 1 ECC LEFT HA; DXTEND MOD EPI 1 ECC LEFT HA; DXTEND MODULAR HUM STEM D12 HA; DXTEND SCREW LOCK D4.5X36MM; DXTEND STAND PE CUP D42 +3MM; DXTEND STAND PE CUP D42 +3MM; UNKNOWN SHOULDER HUMERAL STEMS
• Patient Outcome(s): Required Intervention