MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US RECLAIM PRX BDY CONE 24X85; RECLAIM IMPLANT : HIP FEMORAL STEM

Catalog Number 197524085

Device Problems Use of Device Problem (1670); Osseointegration Problem (3003)

Patient Problems Fall (1848); Inadequate Osseointegration (2646)

Event Date 01/27/2024

Event Type  Injury  

Event Description

It was reported that the patient fell and had implants became loose.Doi: (b)(6) 2024 dor: (b)(6) 2024 affected side : right hip.

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

Additional information received: a.Was there any surgical delay? no surgical delay.B.Can you provide the loosening interface? the surgeon said the proximal body had retroverted.

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.H10 additional narrative: added: b5 and d9 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 : it was reported that the patient fell and had implants became loose.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample reveled that reclaim prx bdy cone 24x85 exhibits signs of use on its surface or due to extraction process.It can be observed that the porous coating did not achieve good integration with the bone, which may be due to the short duration of implantation and the fall, which likely hindered this process.Therefore, it is reasonable to confirm loosening.In the absence of x-ray evidence, the condition of mispositioned cannot be confirmed.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the reclaim prx bdy cone 24x85 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 : a manufacturing record evaluation was performed for the finished device 197524085 / m4340g lot number, and no non-conformances /manufacturing irregularities were identified corrected: h3.

• Brand Name: RECLAIM PRX BDY CONE 24X85
• Type of Device: RECLAIM IMPLANT : HIP FEMORAL STEM
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE RAYNHAM MFG SITE; 325 paramount drive; raynham MA
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19067027
• MDR Text Key: 339666511
• Report Number: 1818910-2024-07771
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295076926
• UDI-Public: 10603295076926
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/08/2024

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: 197524085
• Device Lot Number: M4340G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/24/2024; 05/23/2024
• Supplement Dates FDA Received: 04/25/2024; 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2023
• 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: ALTRX NEUT 36IDX52OD; DELTA CER HEAD 12/14 36MM +8.5; PINN CAN BONE SCREW 6.5MMX25MM; PINN CAN BONE SCREW 6.5MMX30MM; PINN MULTIHOLE W/GRIPTION 52MM
• Patient Outcome(s): Required Intervention