MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US ALTRX NEUT 32IDX48OD; PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS

Catalog Number 122132048

Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Joint Dislocation (2374); Unspecified Musculoskeletal problem (4535)

Event Date 12/19/2023

Event Type  Injury  

Event Description

Hcp reported two consecutive revisions of hip pe-inlays.This complaint is about the second revision.Patient was lifting heavy cement bags and had pain and squeaking in left hip.Xrays show hip head is off center and suspect dislocation.During the revision, osteophytes along the ¿socket edge¿ were identified along with metallosis, a head/liner dislocation and fractured inlay.Doi: (b)(6) 2023; dor: (b)(6) 2023.

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).Investigation summary: according to the information received, "hcp reported two consecutive revisions of hip pe-inlays.This complaint is about the second revision".The product was not returned to depuy synthes, however x-rays were provided for review.See attachments ((b)(4) 20230814 x-rays and (b)(4) 20231218 x-rays).The x-ray investigation revealed that the dlt ts cer hd 12/14 32mm +9 was not properly centered at implant site.This type of condition may happen due to a dissociation between altrx neut 32idx48od and unknown hip acetabular cup.Surgical technique pinnacle ® hip solutions pages 11-12 indicate that "the targeted shell abduction (as measured on radiographs) should be 40-45 degrees taking into account local soft tissue and anatomic landmarks", and "the targeted shell anteversion (as measured on radiographs) should be 15-20 degrees taking into account local soft tissue and anatomic landmarks".Abduction angle of 53 degrees, showed on evidence, confirms a dissociation on liner and cup/shell, suggesting a future fracture or dislocation.However, since quality of x-rays reviewed are poor, no observations pertaining to the nature of the reported event could be identified.Therefore, neither allegation could be confirmed.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the observed condition of the altrx neut 32idx48od would not 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 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 m2614z number, and no non-conformances /manufacturing irregularities were identified.

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: hcp reported two consecutive revisions of hip pe-inlays.This complaint is about the second revision.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.The x-ray investigation revealed that the dlt ts cer hd 12/14 32mm +9 was not properly centered at implant site.This type of condition may happen due to a dissociation between altrx neut 32idx48od and unknown hip acetabular cup.See attachments ((b)(4) (b)(6) x-rays and (b)(4) (b)(6) x-rays).Visual inspection of returned device revealed that altrx neut 32idx48od had one portion of the anti-rotational mechanism fractured, and the device surface deformed.These types of damage are related with a dissociation condition as evidence of the fractured lip of the liner and the eccentric wear on the inside of the liner are indicative of edge loading and ultimately disassociation, resulting in a fracture.Damage can be observed on the next attachment (pal ¿(b)(4)- photos taken by (b)(6) ¿ (b)(6) 2024).Although a definitive cause for eccentric wear and device failure is not established, there are many factors that could contribute to edge loading including the possibility that the acetabular cup was positioned more vertically in the acetabulum per the x-ray images than recommended (greater than 45 degrees inclination is not recommended per the pinnacle hip solutions surgical technique (dsus/jrc/0414/0026)) which could contribute to the eccentric wear and, ultimately, catastrophic failure of the liner and disassociation from the cup.Furthermore, inadvertent, or otherwise, non-compliant patient activities could also contribute to eccentric subluxation putting more pressure on the edge of the liner and causing the liner to fail.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the altrx neut 32idx48od 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: 1) quantity manufactured: (b)(4).2) date of manufacture: 24-feb-2023 3) any anomalies or deviations identified in dhr: no.4) expiry date: 31-jan-2028 5) ifu reference: ifu-0902-00-701.

• Brand Name: ALTRX NEUT 32IDX48OD
• Type of Device: PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18816614
• MDR Text Key: 336662891
• Report Number: 1818910-2024-04827
• Device Sequence Number: 1
• Product Code: LPH
• UDI-Device Identifier: 10603295016090
• UDI-Public: 10603295016090
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K102423
• 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: 03/01/2024

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 Catalogue Number: 122132048
• Device Lot Number: M2614Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 03/28/2024; 04/16/2024; 05/16/2024
• Supplement Dates FDA Received: 04/01/2024; 04/16/2024; 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2023
• 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: DLT TS CER HD 12/14 32MM +9; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention