MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN DEPUY STEM; HIP FEMORAL STEM/SLEEVE

Catalog Number UNK-HIP

Device Problems Corroded (1131); Fracture (1260); Metal Shedding Debris (1804); Appropriate Term/Code Not Available (3191)

Patient Problems Host-Tissue Reaction (1297); Foreign Body Reaction (1868); Memory Loss/Impairment (1958); Pain (1994); Weakness (2145); Osteolysis (2377); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

For any product information received.This complaint is the subject of litigation or a legal claim and currently complete product detail is not available at this time.A follow-up medwatch will be filed as appropriate.This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.

Event Description

Litigation alleges patient was revised to address pain, and elevated ions.A palpable mass was noted to be found in the groin.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.The investigation can draw no conclusion regarding the reported event with the information available.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

Event Description

Update jun 22, 2017: legal medical records received.In addition to what was previously alleged, pfs alleges reduced muscle strength, memory loss, decreased daily activities.After review of the medical records for the mdr reportability, patient was revised due to osteolysis of the greater trochanter.Revision notes stated that there was a large collection of the foreign body reactive granular tissue in the greater trochanter and around the upper portion of the sleeve.There was lysis inferior to the acetabulum and this area was also filled with the granular foreign body type material.It was also reported that the joint fluid was a brownish turbid type consistent with a metal wear.There appeared to be a significant fretting corrosion between the head and the stem.The sleeve and stem were in excellent position and the sleeve was well fixed to the bone.It was also reported that there was some evidence of wear at the trunnion.When the s-rom stem was removed, the posterior limb of the closed pin remained within the femur.The surgeon removed the 2 broken pieces.There was no evidence of any metal shavings or other metallic debris.Inferiorly in the area of the transverse acetabular ligament, there was another collection of this granular material.Mri showed a fluid collection around the hip and had lytic area in the greater trochanter.It was also reported on her radiograph that, patient noted to have a non-displaced linear fracture of the s-rom stem in the distal close pin portion of the stem.Laboratory results for metal ions were below 7ppb.Part/lot information not provided.This complaint was updated on jun 29, 2017.

Manufacturer Narrative

Examination of the reported devices was not possible as they were not returned.A search of the complaints databases and/or a review of device history records were not possible as the required product/lot code combinations were not provided.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

In addition to what was previously alleged, ppf alleges metallosis.

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 device history record (mre) review, was not possible because the required lot code was not provided.

• Brand Name: UNKNOWN DEPUY STEM
• Type of Device: HIP FEMORAL STEM/SLEEVE
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 7000 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 6416027
• MDR Text Key: 70298701
• Report Number: 1818910-2017-14902
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-HIP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 84