MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER HEAD 12/14 32MM +5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Catalog Number 136532320

Device Problem Noise, Audible (3273)

Patient Problems Fall (1848); Pain (1994)

Event Date 10/27/2023

Event Type  Injury  

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.

Event Description

Hip revision left hip.Polyethylene liner failure, fractured.Patient states she slipped, thought nothing of it then woke the next day with left hip adductor pain, as the day progressed she noticed squeaking.She was admitted to hospital and an x-ray was taken showing polyethylene liner fracture.Revision procedure done to remove the liner and replace with pinnacle dual mobility construct.Doi: (b)(6) 2020; doe: (b)(6) 2023; affected side: left.

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: hip revision left hip.Polyethylene liner failure, fractured.Primary [month year].Patient states she slipped, thought nothing of it then woke the next day with left hip adductor pain, as the day progressed she noticed squeaking.She was admitted to hospital and an x-ray was taken showing polyethylene liner fracture.Revision procedure done to remove the liner and replace with pinnacle dual mobility construct.The product was not returned to depuy synthes, however photos were provided for review.See attachment "(b)(4)." review of the photographic evidence found signs of metal transfer on the outer surface of the ceramic head, as a result of a disassociation of the acetabular liner from the cup.The observed condition does not represent a device nonconformance.Based on the observation it is reasonable that noise would be present due to the ceramic head articulating against the metal cup.The overall complaint was confirmed as the observed condition of the delta cer head 12/14 32mm +5 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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : hip revision left hip.Polyethylene liner failure, fractured.Primary [month year].Patient states she slipped, thought nothing of it then woke the next day with left hip adductor pain, as the day progressed she noticed squeaking.She was admitted to hospital and an x-ray was taken showing polyethylene liner fracture.Revision procedure done to remove the liner and replace with pinnacle dual mobility construct.The product was not returned to depuy synthes, however photos were provided for review.Review of the photographic evidence found signs of metal transfer on the outer surface of the ceramic head, as a result of a disassociation of the acetabular liner from the cup.The observed condition does not represent a device nonconformance.Based on the observation it is reasonable that noise would be present due to the ceramic head articulating against the metal cup.The overall complaint was confirmed as the observed condition of the delta cer head 12/14 32mm +5 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 product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.

• Brand Name: DELTA CER HEAD 12/14 32MM +5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): CORK MFG & MATERIAL WAREHOUSE; loughbeg ringaskiddy; cork ; EI
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18075004
• MDR Text Key: 327424778
• Report Number: 1818910-2023-22626
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033448
• UDI-Public: 10603295033448
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K031803
• 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: 11/06/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 136532320
• Device Lot Number: 4601451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 11/17/2023; 11/24/2023; 12/11/2023
• Supplement Dates FDA Received: 11/20/2023; 11/28/2023; 12/11/2023
• Was Device Evaluated by Manufacturer?: No
• 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: ALTRX NEUT 32IDX50OD; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 74 KG