MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. BETA HIP PROSTHESIS; PROSTHESIS, HIP

Model Number N/A

Device Problems Difficult to Insert (1316); Device-Device Incompatibility (2919)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(4).Concomitant medical products: p/n 00801802601, femoral head sterile product do not resterilize 12/14 taper, l/n 63659466; p/n 2845, alloclassicâ®, sl stem, uncemented, 5, taper 12/14, l/n 2879479; p/n 00500105000, shell 50 mm o.D., l/n 63146931; p/n 00500105026, liner 26 mm i.D.For use with 50/51/52 mm o.D.Shells, l/n 63135319.It was initially reported the device(s) would be returned for evaluation.Evaluation is anticipated, however, the device has not been received by the manufacturer to date.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the device would not assemble with its mating device.A delay of 0-15 minutes was reported.Follow up attempts were performed but no further information has been provided.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.As returned, damage is seen on the articulating surface.The conical taper shows no damage.Dimensional analysis was measured and is conforming to print specifications.Device history record (dhr) was reviewed and no discrepancies relevant to the reported event were found.The complaint was not confirmed and device analysis indicated that the device met specification.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: BETA HIP PROSTHESIS
• Type of Device: PROSTHESIS, HIP
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6845666
• MDR Text Key: 85442876
• Report Number: 0002648920-2017-00544
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK953337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 00801802601
• Device Lot Number: 63659466
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1