MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EA DELTA CER INSERT 36IDX54OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number 121881754

Device Problems Fracture (1260); Noise, Audible (3273)

Patient Problems Fall (1848); Pain (1994); Ambulation Difficulties (2544); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 04/22/2020

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

Received a x-ray of a post thr patient, seems a brocken stem from the neck and looks jnj corail pinnacle product.Patient was complaining severe pain in right side of hip, inability to stand and inability to walk.Patient also informed surgeon that he got fallen during his routine work.Patient also informed to surgeon that his right hip was already operated in 2018 due to avn by any other surgeon from the patna, & rt hip was implanted with jnj product.And patient has also reported that he is having pain in his rt hip (operated site) and getting some unusual sound since last one year.

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.

Event Description

Implant photos received showed that the ceramic insert was fractured.

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.Additional narrative:  h6 patient code: no code available ((b)(6)) used to capture the surgery prolonged 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 #
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>(b)(4).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.H10 additional narrative: added: e1 (facility name), h6 (patient).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: following review of the information received, it was concluded that it was unlikely that a potential product issue was present.The complaint shall be entered onto the complaints database and monitored through trend analysis.Should further information be received, then the complaint shall be reviewed and further investigation completed as required.

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 : today morning around 10 am, i received a x-ray of a post thr patient, seems a brocken stem from the neck and looks jnj corail pinnacle product.After that got a call form surgeon also, he described about the event that, yesterday evening he has got a young patient in his emergency department, patient was complaining severe pain in right side of hip, inability to stand and inability to walk.Patient also informed surgeonl that he got fallen during his routine work.Patient also informed to surgeon that his right hip was already operated in 2018 due to avn by any other surgeon from the patna, & rt hip was implanted with jnj product.And patient has also reported that he is having pain in his rt hip (operated site) and getting some unusual sound since last one year.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device along with supplier investigation performed by supplier.Further details of the device's analysis were attached on "230822 final report kiv 22 01 12".Visual analysis of the returned sample revealed that the rim of the ea delta cer insert 36idx54od has fractured, the fragments have been chafing against each other causing a secondary chip-offs on the fractured surfaces.The broken fragments were not returned for evaluation.Additionally, metal transfer can be found on the outer surface, on the inner sphere and on the fracture surfaces of the insert, most likely caused by chafing between metal parts and / or surgical instruments.However, there is not enough evidence to determine if audible sound could be caused by the liner and another device, therefore the reported allegations can be partially confirmed.With the information provided is not possible to determine a potential cause at this moment, however in support of the evaluation performed, the observed damage of the ea delta cer insert 36idx54od may have been caused by the reported fall of the patient.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables, anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A manufacturing record evaluation was performed for the finished device [121881754 / 8528400] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.The density of the insert was analyzed and found to comply with the delivery specification for biolox® delta components.The microstructure as obtained from the quality documents of both components meets the requirements specified at the time of production, too.There is no indication of any pre-existing material defect.The overall complaint was confirmed as the observed condition of the ea delta cer insert 36idx54od would contribute to the complained device issue.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 : the ceramic insert belongs to the shop order (b)(4).Protocols and acceptance certificate were reviewed.The quality documents show that the data obtained on the insert confirmed to the specification valid at the time of production.The density was determined on the fragment insert.The measured average relative bulk density complies with the delivery specifications of biolox® delta components (= 99%).The microstructure as obtained from the quality documents meets the requirements specified at the time of productions.There is no indication of any pre-existing material defect.Device history review : a manufacturing record evaluation was performed for the finished device [121881754 / 8528400] number, and no non-conformances / manufacturing irregularities were identified during manufacturing.

• Brand Name: EA DELTA CER INSERT 36IDX54OD
• Type of Device: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10022551
• MDR Text Key: 189888846
• Report Number: 1818910-2020-11665
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 121881754
• Device Lot Number: 8528400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• 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: CANCELLOUS BONE SCREW 6.5X20MM; CANCELLOUS BONE SCREW 6.5X30MM; CORAIL2 STD SIZE 13; DELTA CER HEAD 12/14 36MM +8.5; EA DELTA CER INSERT 36IDX54OD; PINNACLE SECTOR II CUP 54MM
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male