MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SELF CENT HIP 45X28 GRY; HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI

Catalog Number 103545000

Device Problem Difficult to Insert (1316)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

The "bipolar self-centering" implant is made up of two pieces that should fit together.However, in the batch in question this does not happen, when i try to fit one component to another it falls.

Manufacturer Narrative

Product complaint # (b)(4).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).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).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).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 according to the information received, ¿the "bipolar self-centering" implant is made up of two pieces that should fit together.However, in the batch in question this does not happen, when i try to fit one component to another it falls¿.The product was returned to depuy synthes for evaluation.The depuy synthes team forwarded the device to the warsaw commercialized product development engineer team and subsequently to the depuy synthes suzhou for for further investigation of the manufacturing and assembly process.The following results were observed: a visual inspection of the device was conducted.This product code consists of three separate subcomponents.All three were returned and reviewed in this investigation.The polyethene insert and collar components were returned assembled, however the insert-collar assembly was received separated from the metal shell component.Visually, there was no noticeable damage or defects with any of the components.However it is worth mentioning that the gap in the collar appeared to be smaller than normal.Furthermore, upon magnification of the outer surface of the insert component, there appears to be a faint imprint of the product code etched on the inside of the shell component.This is consistent with the insert being overheated causing the poly material of the insert to deform while inside the metal shell.A functional evaluation was performed by assembling the insert and collar with the shell.Once assembled, the complaint condition was confirmed wherein the components failed to lock together as intended.In fact, both the insert and collar felt slightly loose inside the shell and would fall out without any resistance.During the evaluation, an attempt was made to assemble a production equivalent 28mm femoral head with the insert.However, it was observed that the head could not fully fit into the insert, indicating that the insert appeared to be slightly undersized.Measurements were taken of the metal shell, poly insert, and poly collar utilizing calipers (id# (b)(4) while the components were disassembled.The measurements taken on the poly insert showed that the insert was undersized and out of tolerance per the specifications of drawing dwg-103502001 rev.D.Measurements taken on the collar showed the gap in the collar was too small and out of tolerance per the specifications of drawing dwg-103502002 rev.J.The shell component was conforming per dwg-103545000 rev h.Additional information from the hospital informed customer quality that their decontamination machine washes at 93ºc, and the drying step goes up to 115ºc.This information confirms the possibility that the insert may have inadvertently been exposed to high temperatures prior to the observations made in the complaint.However, without further confirmation of this part entering decontamination prior to the event, no further conclusion can be drawn at this time.Further review of the manufacturing process was performed.Review of the dhr¿s for the finished good lot d22073960 as well as the insert and collar components lots that were utilized (m0069z, m0102d, d220012569 ) did not identify any anomalies in the manufacturing process.Reviewing the detection points that exist for this product, it was determined that once the cleaning process of the finished good is completed, the assembly of the product is verified through a functional testing with a ball gauge as per "clean room inspection assy& pack" process.The inspection results for the finished device [103545000 / d22073960] were within specifications; no reworks were required in the clean room inspection assy& pack and following operations.Additionally, it was identified that there is nothing in the manufacturing process where the product could be exposed to high temperatures that could compromise the dimensional integrity.Based on the information available, a potential cause could not be traced to a manufacturing issue.The overall complaint was confirmed as the undersized condition of the insert and collar components would have contribute to the inability to assemble the self cent hip 45x28 gry as design intended.The dimensional integrity of the poly components could be compromise by the exposure to an environment of high temperatures.However, based on the information of the manufacturing investigation and without further confirmation of this part entering decontamination prior to the event; the potential cause could not be established.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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 was performed for the finished device [103545000 / d22073960] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: SELF CENT HIP 45X28 GRY
• Type of Device: HEMI HIP IMPLANT : HIP ACETABULAR POLY/METAL HEMI
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 17897742
• MDR Text Key: 325249967
• Report Number: 1818910-2023-20521
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 10603295003359
• UDI-Public: 10603295003359
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K812672
• 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
• Report Date: 10/09/2023

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: 103545000
• Device Lot Number: D22073960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 10/20/2023; 11/21/2023; 12/05/2023
• Supplement Dates FDA Received: 10/24/2023; 11/23/2023; 12/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/29/2022
• 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: SELF CENT HIP 45X28 GRY.; UNK HIP ACETABULAR LINER POLY.