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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS
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DEPUY ORTHOPAEDICS INC US UNKNOWN HIP ACETABULAR LINERS Back to Search Results
Catalog Number UNK HIP ACETABULAR LINER
Device Problem Naturally Worn (2988)
Patient Problems Pain (1994); Loss of Range of Motion (2032); Osteolysis (2377); Ambulation Difficulties (2544); Physical Asymmetry (4573); Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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
Surgeon is reporting a planned revision of pe-inlay and hip-head because of normal and expected duraloc pe-inlay-wear unknown side.Doi: unknown, but > 10 years ago in (b)(6), probably (b)(6).Dor: (planned) 2021.There has been no allegation of any product deficiency.
 
Event Description
On (b)(6) 2020, the patient presented for a minimally invasive diagnostic hip tap procedure to rule-out infection of the right hip.The patient presented with "polyethylene wear of enclosed total hip endoprosthesis on the right with osteolysis in gruen zones 1 and 7, as well as charnley zone 1", and had been scheduled for revision surgery to address the polyethylene wear and osteolysis affecting the femur and the acetabulum.The procedure was completed using radiographic imaging without complications.The patient had significantly increasing complaints in the right femoral joint for about 3 months.No triggering trauma was identified.Mobility and weight bearing have been significantly reduced.Clinically, no sign of infection.On right, the patient presented with pronounced limping gait pattern.Mobility in the right femoral joint was extension/flexion 0/0/70°, outer rotation/inner rotation 10/0/0°, abduction/adduction 10/0/0°.Mobility was reportedly limited due to pain.Pain on pressure at groin, trochanter muscle free.Difference in leg length on the right was -2 cm compared to left.X-ray result of the right femoral joint on 2 levels dated (b)(6) 2020 showed a total hip endoprosthesis on the right with cup in secondary cup position, about 2 cm above the original cup center.The cup was affixed with 2 cranial screws.Main finding was the metal femoral head that was positioned significantly decentralized cranially in the polyethylene inlay.Osteolysis along the cranial screws in charnley zone 1.Similarly, osteolysis in grün zones 1 and 7 of the femur.The treatment recommendation: as the trigger was the advanced polyethylene wear, with significant osteolysis on the proximal femur and on the acetabulum, a diagnostic tap of the right femoral joint would be performed to exclude peri-implant infection, followed by a subsequent revision of the total hip endoprosthesis on the right, replacing at least the articulating components (head and liner).A ct scan [computed tomography image] of the right femur was ordered; to evaluate the extent of osteolysis.Depending on the ct findings, replacing the cup would be considered.
 
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.H10 additional narrative: added: b1 (adverse event), b2, b5 corrected: h1, h6 (clinical and impact codes), h8.
 
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).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 : examination of the returned device confirmed the reported wear.There was no evidence to suggest product error in material or manufacturing was a factor in the need for revision surgery.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Device history lot : a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.
 
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: if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h6 (patient).Replaced surgical intervention with device revision or replacement.
 
Event Description
Add.Info requested by bfarm: date of revision: (b)(6) 2021.Only a depuy hip-head was used: ref (b)(4), elite femoral head +3 9/10 taper lot d20061282.Inlay change was not possible, so the entire cup was replaced.Competitor components used.Details see attachement (b)(4), implants inserted during revision (b)(6).
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported wear.There was no evidence to suggest product error in material or manufacturing was a factor in the need for revision surgery.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Update 21-jul-2021: the investigation was re-opened upon receipt of additional information.The new information does not affect the existing investigation.Device history lot: a worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot number was not provided.
 
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Brand Name
UNKNOWN HIP ACETABULAR LINERS
Type of Device
HIP ACETABULAR LINERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key11019740
MDR Text Key222412495
Report Number1818910-2020-27050
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 12/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK HIP ACETABULAR LINER
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2021
Date Manufacturer Received07/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AML STEM; AML STEM; DURALOC INLAY; DURALOC SECTOR SERIES 52OD; UNK HIP BONE SCREW; UNK HIP FEMORAL HEAD METAL; UNK HIP LOCKING RING
Patient Outcome(s) Required Intervention;
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