MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM*STM ST,36+8L NK,18X13X160; S-ROM HIP SYSTEM : HIP FEMORAL STEM

Model Number 52-3418

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060); Distress (2329); Metal Related Pathology (4530); Muscle/Tendon Damage (4532); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter occupation: lawyer.(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

(b)(6) mom litigation record received.Litigation alleges heavy metal poisoning for heavy metal released resulting to injury to muscle, tissues, scar tissue formation, metal wear , limited adl.And pain.Plaintiff also suffered emotional trauma and distress.Doi: (b)(6) 2009; dor: (b)(6) 2021 ; unknown hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.Device history lot a manufacturing record evaluation (mre), was not possible because the required lot code was not provided.

Event Description

Medical records were received and stated the following: there was evidence of local metallosis and alval with exaggerated biological reaction without detachment or compromise of the gluteus medius tendon.A large sterile joint effusion encountered upon entering the joint space.Recent serum cobalt and chromium levels showed elevated ions.Mri scan with metal artifact reduction series shows extensive periarticular adverse local tissue reaction related to the prosthetic device.Doi: (b)(6) 2009; dor: (b)(6) 2021 ; affected side: right hip.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.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 no device associated with this report was received for examination.Review of the x-ray evidence found nothing indicative of a device nonconformance or a relation of the product with the reported adverse event.  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).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: b6, b7.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.H10 additional narrative: added: b1 (is product problem) and b5 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H6 (device code).

Event Description

Medical records were received, in addition to what was reported.The patient was revised due to altr, corrosion, and joint effusion.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: according to the information received, "pinnacle mom litigation record received.Litigation alleges heavy metal poisoning for heavy metal released resulting to injury to muscle, tissues, scar tissue formation, metal wear , limited adl.And pain.Plaintiff also suffered emotional trauma and distress.Doi: (b)(6) 2009; dor: (b)(6)2021 ; unknown hip".The x-ray was returned to depuy synthes for evaluation.The depuy synthes team conducted a x-ray review from attachment "(b)(4) x-ray images ad (b)(6) 2023".The x-ray evidence review revealed that the srom*stm st,36+8l nk,18x13x160 (523418 / 2933877) presented no evidence of a device nonconformance or a relation of the product with the reported adverse event.  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.

• Type of Device: S-ROM HIP SYSTEM : HIP FEMORAL STEM
• 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 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 13976812
• MDR Text Key: 288375564
• Report Number: 1818910-2022-05957
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: 10603295171034
• UDI-Public: 10603295171034
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: 52-3418
• Device Catalogue Number: 523418
• Device Lot Number: 2933877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2009
• 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: PINN CAN BONE SCREW 6.5MMX40MM; PINN SECTOR W/GRIPTION 56MM; PINNACLE MTL INS NEUT36IDX56OD; S-ROM M HEAD 36MM +9; SROM*STM ST,36+8L NK,18X13X160; UNK HIP ACETABULAR LINER METAL PINNACLE; UNK HIP FEMORAL HEAD METAL
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female