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

Catalog Number UNK HIP FEMORAL STEM

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Osseointegration Problem (3003)

Patient Problems Unspecified Infection (1930); Pain (1994); Ambulation Difficulties (2544); Inadequate Osseointegration (2646); Thrombosis/Thrombus (4440); Limb Fracture (4518); Physical Asymmetry (4573)

Event Date 04/22/2019

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

Article entitled "long-term outcomes of ultra-short metaphyseal-fitting anatomic cementless femoral stem in total hip arthroplasty with ceramic-on-ceramic articulation for young patients" written by young-hoo kim, md and jang-won park, md published by the journal of arthroplasty on april 22, 2019 was reviewed.The purpose of study of the current series is to determine longer term clinical results, radiographic results, and computerized tomographic (ct) scan results in patients younger than 50 years old.Furthermore, the survival rate of the components and complication rates were determined.239 patient (324 hips) were included in the study.273 hips had a pinnacle cup and 51 hips had a duraloc cup.All cups were press fit and 15 hips had 1-2 screws for additional fixation.Ceramic liner was noted to have been used.Proxima stems were used with a ceramic head.Adverse events: 31 hips had a mild limp due to leg length discrepancy.No treatment noted.10 hips had a mild limp due to low back pain.No treatment noted.3 hips had moderate thigh pain due to aseptic loosening of the femoral component.All three loose femoral stems were revised.2 hips indicated to have a dvt.No treatment noted.2 hips had dislocations within 2 weeks of the operation and were treated successfully with closed reductions.2 hips had periprosthetic fracture after a fall at 2 and 3 months after the operation.One of these hips had a revision of the stem due to loosening which wasn¿t loose prior to the fall.The other fracture had an open reduction and internal fixation of the fracture.3 hips had superficial infection and these were treated with iv antibiotics for 2 weeks.41 hips had squeaking/clicking sounds.No treatment noted.Acetabular position was noted to be outside of the recommended surgical technique (inclination was 35-50 degrees and anteversion was 19-26 degrees).No treatment noted.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.Available xray evidence was reviewed.Based in attached photographic evidence, it cannot be determinate a depuy's device failure or malfunction which could contribute to reported event.No loosening condition was observed.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation may be re-opened as necessary.Device history lot : a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.

• Brand Name: UNKNOWN HIP FEMORAL STEM
• Type of Device: 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: 14141785
• MDR Text Key: 289505579
• Report Number: 1818910-2022-06994
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

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: UNK HIP FEMORAL STEM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 06/27/2022
• Supplement Dates FDA Received: 06/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: UNKNOWN HIP ACETABULAR CUP; UNKNOWN HIP ACETABULAR LINERS; UNKNOWN HIP FEMORAL HEAD; UNKNOWN HIP IMPLANT; UNKNOWN HIP IMPLANT
• Patient Outcome(s): Required Intervention