MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTA CER INSERT 32ID X 50OD; PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS

Catalog Number 121882750

Device Problems Fracture (1260); Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

Ceramic insert was broken during placement and adjustment.

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.

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.

Event Description

Additional information received indicated that a large part of the product was implanted when the edge of product was cracked.Hence, it was difficult to remove from the patient and then implanted a new product.The doctor judged that cracked edge did not impact on function and patient health so continued the use of product.The main product was implanted based on doctor¿s decision.

Manufacturer Narrative

Product complaint #
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> (b)(4) investigation summary
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> the device associated with this report was received for analysis.Visual examination of the returned device confirmed the reported event.The ceramic insert was fractured and only a portion of the rim was returned for examination.Based in the provided information, it cannot be definitely confirmed thta device was used in a manner for which it is not labeled or intended by the manufacturer.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
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> the ceramic insert belongs to the shop order (b)(4).Protocols and certificate of conformance were reviewed.The quality documents show that the data obtained on the insert confirmed to the specification valid at the time of production.The component properties and the microstructure as obtained from the quality documents fulfil the requirements as specified at the time of production.There is no indication of any pre-existing material defect.Manufacturing record evaluation was performed for the finished device (121882750/9661697) product and lot numbers, and no non-conformances were identified.

• Brand Name: DELTA CER INSERT 32ID X 50OD
• Type of Device: PINNACLE HIP SYSTEM : HIP CERAMIC ACETABULAR LINERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg ringaskiddy co.; cork IN ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13013870
• MDR Text Key: 283171668
• Report Number: 1818910-2021-28249
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 121882750
• Device Lot Number: 9661697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 01/12/2022; 07/01/2022
• Supplement Dates FDA Received: 01/14/2022; 07/01/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/15/2020
• 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