MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DLT TS CER HD 12/14 36MM +1.5; ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS

Model Number 1365-36-710

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscular Rigidity (1968); Pain (1994); Weakness (2145); Discomfort (2330); Ambulation Difficulties (2544); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(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

Medical records received.After review of medical records, visit notes on (b)(6) 2018 indicated that patient had complaints of occasional stiffness and soreness.Visit notes on (b)(6) 2019 reported that patient had a lower lumbar pain bilateral lower extremity pain into the posterior thigh, quad and posterior calves.Urologist consultation reported that patient prostate was enlarge.Doi: (b)(6) 2009 (cup), doi: (b)(6) 2017; dor: none reported; left hip.

Manufacturer Narrative

Product complaint # (b)(4).No device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.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

After review of medical records, it was reported during patient visit, that the patient has generalized muscle weakness and other abnormalities of gait and mobility.It was indicated that the patient has redness around the incision site, no drainage and no fever.

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 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 no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.Corrected: h6 (patient) by removing code (back pain).

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned for analysis.All available x-rays were reviewed, a fracture of the stem was observed.However, no evidence of fracture, disassociation, or anything indicative of a device nonconformance was found for dlt ts cer hd 12/14 36mm +1.5.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 : 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.

• Brand Name: DLT TS CER HD 12/14 36MM +1.5
• Type of Device: ARTICULEZE HEAD (12/14 TAPER) : HIP CERAMIC FEMORAL HEADS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic drive; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 10272070
• MDR Text Key: 198757626
• Report Number: 1818910-2020-15824
• Device Sequence Number: 1
• Product Code: LZO
• UDI-Device Identifier: 10603295033653
• UDI-Public: 10603295033653
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/02/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 1365-36-710
• Device Catalogue Number: 136536710
• Device Lot Number: 8433055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 08/24/2020; 08/20/2020; 01/07/2021; 01/19/2023
• Supplement Dates FDA Received: 08/24/2020; 08/27/2020; 01/11/2021; 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2016
• 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; SOL SYS 8/18.0 LRG ST; UNKNOWN HIP ACETABULAR CUP; ALTRX NEUT 36IDX52OD; SOL SYS 8/18.0 LRG ST; UNKNOWN HIP ACETABULAR CUP
• Patient Outcome(s): Required Intervention
• Patient Sex: Male