MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ARTICUL/EZE BALL 28 +8.5 BL; ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS

Catalog Number 136513000

Device Problems Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

The primary and the secondary packaging were torn at the opening of the device leading a desterilization risk.When giving the implant during the intervention, the primary packaging opened incorrectly.When opening the second packaging, it also opened incorrectly.The femoral head could not be removed from the box.There was no patient consequence or surgical delay.

Manufacturer Narrative

Product complaint # (b)(4).B3: date of event is an unknown date.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).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the primary and the secondary packaging were torn at the opening of the device leading a desterilization risk : when giving the implant during the intervention, the primary packaging opened incorrectly.When opening the second packaging, it also opened incorrectly.The femoral head could be removed from the box.The product was returned to depuy synthes for evaluation.The depuy synthes team forwarded a photo evidence to depuy suzhou which conducted a visual inspection of the provided evidence.Product review was conducted according to the provided information.Carton box was not broken.The blister box is in good condition and there is no deformation problem.In addition, it can be seen from the edge of the outer blister box, which indicates that the glue transfer between the outer blister box and tyvek has been completed.And there are no winding edge, cavity or other defects.It can be seen that both the inner and outer packaging of the product are torn the same way.The same as the outer blister box, the glue transfer has been completed on the inner packaging.Through the fracture area observation, the inner and outer packaging have gone through the same direction.This failure mode wasn¿t related to the production process.The root cause of the complaint cannot be determined.The details can refer the the attachment "(b)(4) articul package broken investigation summary".A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of thearticul/eze ball 28 +8.5 bl would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Device history lot : 1) quantity manufactured: (b)(4) pcs 2) date of manufacture: 18-may-2022 3) any anomalies or deviations identified in dhr: no nonconformities were identified.4) expiry date: 30-apr-2027 5) ifu reference: ifu-0902-00-701.Product code 136513000, lot number d22051790 was manufactured on 18-may-2022.(b)(4) pcs parts were manufactured per specification and all raw material met specification.No non-conformances / manufacturing irregularities were identified.The expiry date is 30-apr-2027.Ifu reference no.Ifu reference: ifu-0902-00-701.Device history review : product code 136513000, lot number d22051790 was manufactured on 18-may-2022.(b)(4) pcs parts were manufactured per specification and all raw material met specification.No non-conformances / manufacturing irregularities were identified.The expiry date is 30-apr-2027.Ifu reference no.Ifu-0902-00-701.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the primary and the secondary packaging were torn at the opening of the device leading a desterilization risk : when giving the implant during the intervention, the primary packaging opened incorrectly.When opening the second packaging, it also opened incorrectly.The femoral head could be removed from the box.The product was returned to depuy synthes for evaluation.The depuy synthes team forwarded a photo evidence to depuy suzhou which conducted a visual inspection of the provided evidence.Product review was conducted according to the provided information.Carton box was not broken.The blister box is in good condition and there is no deformation problem.In addition, it can be seen from the edge of the outer blister box, which indicates that the glue transfer between the outer blister box and tyvek has been completed.And there are no winding edge, cavity or other defects.It can be seen that both the inner and outer packaging of the product are torn the same way.The same as the outer blister box, the glue transfer has been completed on the inner packaging.Through the fracture area observation, the inner and outer packaging have gone through the same direction.This failure mode wasn¿t related to the production process.The root cause of the complaint cannot be determined.The details can refer the the attachment "(b)(4) articul package broken investigation summary".A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of thearticul/eze ball 28 +8.5 bl would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Device history lot: 1) quantity manufactured: (b)(4).2) date of manufacture: 18-may-2022.3) any anomalies or deviations identified in dhr: no nonconformities were identified.4) expiry date: 30-apr-2027.5) ifu reference: ifu-0902-00-701.Product code 136513000, lot number d22051790 was manufactured on 18-may-2022.(b)(4) parts were manufactured per specification and all raw material met specification.No non-conformances / manufacturing irregularities were identified.The expiry date is 30-apr-2027.Ifu reference no.Is ifu-0902-00-701.

• Brand Name: ARTICUL/EZE BALL 28 +8.5 BL
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JJMSZ PLANT FOR STK. & N-STK.; no. 299, changyang street; suzhou industrial park; suzhou, jiangsu
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18409660
• MDR Text Key: 331502582
• Report Number: 1818910-2023-26116
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 10603295033103
• UDI-Public: 10603295033103
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K883460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 136513000
• Device Lot Number: D22051790
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/25/2024; 03/08/2024; 04/12/2024
• Supplement Dates FDA Received: 01/26/2024; 03/11/2024; 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1